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Additional information received from the reporter on 6/25/2021 for a report number mw5102138.I am submitting the following complaint against freedom laser therapy, inc., located at (b)(4) with an email address of (b)(4).Website ¿ www.Irestorelaser.Com.My intent of writing this letter is to request that the food and drug administration reevaluate the safety of freedom laser therapy¿s product, irestore laser helmets.My sole purpose of doing so is to protect any current or potential freedom laser therapy clients.I am likewise requesting that the fda review any false or misleading statements that appear on the irestore website.The following is a brief summary of the experience i had in regards to using freedom laser therapy¿s product, irestore professional 282 laser helmet.My interest in using the irestore professional 282 laser helmet was due to the fact that hair thinning runs in my family.In (b)(6) 2019, i visited the freedom laser therapy, inc.Irestore website at www.Irestorelaser.Com.After reading the positive results listed on their website as well as irestore assuring the safety of their laser therapy helmet i decided to purchase the irestore professional 282 helmet.The main reason that i chose irestore opposed to other treatment options was due to the diagram displayed on irestore¿s website which states that ¿100% of irestore users grew hair in the 4-month study.¿ after receiving the irestore laser helmet i began using it as directed.This photo is a picture of my hair that was taken on the day that i received the irestore laser helmet from (b)(6).After using the irestore helmet for four months i began experiencing a high amount of hair loss that irestore refers to as ¿shedding.¿ irestore explained that shedding is a normal process while using the irestore laser helmet, which enables weaker hair to fall out which is replaced by thicker, stronger hair.In (b)(6) 2019, four months after i began using the irestore helmet.During that time, i emailed irestore at (b)(4) on wednesday, (b)(6) 2019.Two days later on friday, (b)(6) 2019, i received a reply email from (b)(4) at irestore.At the end of (b)(4) first paragraph he stated that ¿[irestore is] confident that lowlevel light therapy can stop your hair loss with continued usage.Stay consistent and we expect you to start noticing a positive improvement in your hair condition.¿ although i was very nervous in regards to continuing to use irestore, i followed (b)(4) advice and continued using the irestore helmet.As my hair loss continued to worsen i began having significant hair loss from the front of my head to the back of my head.As i continued to use the irestore helmet i developed two large and one medium size cysts on the back of my head where i had the greatest amount of hair loss.Soon all three of these cysts began bleeding and were extremely painful.Due to the painful, bleeding cysts i returned the irestore helmet in (b)(6) 2020.At that point i had became very frustrated due to the damage that the irestore laser helmet had done to my hair and scalp.Prior to using the irestore laser helmet my dermatologist, dr.(b)(6) said that my hair loss was very minimal and that i should not be concerned about hair loss treatments at that time.Dr.(b)(6) said that if i began having noticeable hair loss in the future to make an appointment with him to discuss oral medication treatment.Dr.(b)(6) likewise informed me that if i wanted to research hair restoration products he suggested that i research laser therapy as a possible option.By (b)(6) 2021, nine months after i had returned the irestore professional 282 helmet my hair had not regrown.During that time i determined that my hair loss was permanent and filed a complaint with the (b)(6).A current photo of my hair loss.The reason why i decided to wait nine months after returning the irestore laser helmet to freedom laser therapy before submitting a complaint to the (b)(6) was to give myself the opportunity for my hair to regrow, hoping that the damage that the irestore laser helmet had caused was only temporary.I wanted to give my hair every opportunity to regrow but it never did.I feel that a lot of the statements made on the irestore website (www.Irestorelaser.Com) are either incorrect or misleading.Prior to purchasing the irestore laser helmet, i read the customer reviews exclusively on the irestore website.After returning the irestore laser helmet in (b)(6) 2020, i began reading irestore testimonials from other websites and realized how dangerous the irestore helmet could be.I have included reviews from the (b)(6) website from customers who experienced adverse reactions as a result of using the irestore helmet.Some of the customers complained that the irestore helmet created greater hair loss, severe headaches, itchy scalp, unbearable pain, eye irritation, sleeplessness due to headaches, rash, scalp damage, scalp pain, inner ear pain, as well as many other serious side effects.It was very difficult and frustrating for me to read these testimonials since i could easily empathize with each of the irestore users who had been harmed by the irestore laser helmet.I would like to discuss the areas of the irestore website which i feel is misleading and inaccurate.Taken from the irestore website which states that ¿our users have never reported adverse side effects or been harmed from the use of our device.Only misuse of the devise, such as staring directly into the lasers, can cause harm or injury.¿ if you review the statements that i am submitting, taken from the (b)(6) website, it is in fact evident that irestore users have experienced side effects and have been harmed by the use of the irestore laser helmet.Taken from the irestore website, goes on to state that ¿there are no negative side effects when using the low-level light therapy (lllt).Our device has been cleared by the fda for both safety and efficacy, and our users have had no reports of adverse reactions.¿ states that, ¿low-level light therapy (lllt) treats genetic hair loss and allows users to have long term success without experiencing an increase in health risks.¿ i feel that the negative reviews which are posted on the irestore website are bias and misleading.Their reviews do not reveal the long term, irreversible damage that consumers have suffered from as a result of using the irestore laser helmet.The reviews that are posted on the irestore website makes the consumer believe that the customers who are writing the negative reviews have not used the irestore helmet long enough to be able to submit a full review.After returning the irestore professional 282 laser helmet to freedom laser therapy, i contacted (b)(6) and they informed me that the only way to restore my hair to the way it was prior to using the irestore helmet is through a hair transplant.At that time they gave me a quote of (b)(6) to restore my hair.During that time they were offering a 40% discount for that particular month.The quote that they had given me of (b)(6) included the 40% discount.On (b)(6) 2021, i submitted a similar complaint letter with the (b)(6) and i was contacted by senior vice president of freedom laser therapy, (b)(4) and i emailed and spoke to each other on the telephone during an approximate two week period.Mr.(b)(4) called me on tuesday, (b)(6) 2021 and offered a (b)(6) settlement.Initially, i accepted his settlement but after further consideration i decided not to accept his offer.If i accepted mr.(b)(4) offer of (b)(6) and had my hair restored i would be required to pay (b)(6) an additional (b)(6).While speaking to mr.(b)(4) i informed him that i was told by (b)(6) that the anesthetics alone would be (b)(6).At that time mr.(b)(4) informed me that their settlement was non-negotiable.I knew that if i accepted mr.(b)(4) settlement that it would create a lot of frustration for me and that i would be forfeiting a future settlement if i decide to seek legal advise.The main reason why i filed a complaint with the (b)(6) and currently with the fda is not to receive a settlement but to warn freedom laser therapy¿s current as well as potential clients in regards to the health issues and permanent hair loss that can result from the use of the irestore laser helmet.While speaking to mr.(b)(4) on the telephone i asked him why his website states that no one has suffered any side effects to the irestore laser helmet.Within my complaint letter to the (b)(6) i submitted several examples of irestore clients from the (b)(6) website who suffered severe side effects.Mr.(b)(4) informed me that freedom laser therapy only recognizes complaints that are submitted through the fda.Since the irestore website states that not one client has suffered any side effects while using the irestore laser helmet then i am assuming that i am the first client to submit a complaint to the fda.Now that my complaint has been submitted with the fda, freedom laser therapy can now recognize this letter as a formal complaint, which has been submitted to the fda.After submitting my complaint letter to the (b)(6), mr.(b)(4) submitted the following reply to the (b)(6).In the first paragraph of mr.(b)(4) reply, mr.(b)(4) stated that my experience with irestore laser helmet is atypical.If you examine the complaints that i submitted to mr.(b)(4) and freedom laser therapy that my experience is not atypical, that an overwhelming amount of clients using the irestore laser helmet have suffered serious side effects.After speaking to mr.(b)(4) i was surprised that freedom laser therapy only recognizes complaints that are submitted through the fda and disregards all other complaints.Within the same paragraph mr.(b)(4) stated, ¿we would like to rectify this issue with mr.(b)(6) directly and have attempted to do so prior to receiving this complaint, but have thus far been met with no response.¿ an email that i sent to freedom laser therapy in regards to the issues that i had with the irestore laser helmet.The response that i received from freedom laser therapy was to continue using the helmet even though it was creating significant hair loss.In mr.(b)(4) second paragraph he stated, ¿as far as mr.(b)(6) complaint regarding shedding, this is a normal part of the process and we believe we did our due diligence to make him aware of that.¿ mr.(b)(4) and (b)(4), as well as the irestore website did state that shedding is a part of the hair regrowth process but in my situation as well as many others, shedding did not create hair regrowth, instead it created permanent hair loss.Irestore¿s representative, (b)(4) emailed me and stated that ¿some people may experience an increase in shedding within the first few months.This is due to the cycle of hair growth is accelerated, stimulating the follicles to release the brittle and thinning hair.This prepares the scalp for the new healthier, stronger hair to grow in its place.¿ it is stated on irestore¿s webpage ¿for most hair loss solutions, it is perfectly normal for some users to see shedding in the beginning as weaker, thin hairs are shed to be replaced by stronger, thicker hairs.Low-level light therapy (lllt) is not expected to make hair loss worse because it is designed to combat genetic hair loss.¿ the irestore helmet did cause ¿shedding¿ but instead of creating hair regrowth, it created permanent hair loss.I feel that irestore¿s representatives as well as the irestore website needs to warn consumers that the irestore laser helmet can cause permanent, irreversible hair loss.If a warning had been stated on their website i would never have used their product and i would not have suffered irreversible hair loss.The hair loss that i experienced was not atypical as mr.(b)(4) stated.Others, as well as myself, have experienced permanent hair loss due to the use of the irestore laser helmet.Within mr.(b)(4)¿s letter he stated,¿ if he was not satisfied with the results he was getting he could have simply stopped using the product and received a refund.¿ on (b)(6) 2020, i attempted to return the irestore laser helmet as well as the rechargeable battery.I was told by irestore that if i returned the irestore laser helmet within one year that they would charge me a restocking fee and that the rechargeable battery was non-refundable.They stated that in order to receive a full refund that i would have to keep the irestore laser helmet as well as the rechargeable battery for a full year.Mr.(b)(4) was partially correct in regards to his statement.I could have returned the irestore helmet but i would not have received a full refund and i would not have received any refund for the rechargeable battery pack if i returned it on (b)(6) 2020.In mr.(b)(4)¿s third paragraph he refers to the fact that i had developed cysts on my head due the use of the irestore laser helmet.Mr.(b)(4) went on to state, ¿if the product was used according to the instructions manual then there should be no issue.¿ for me this was the biggest reason why i am submitting my complaint to the food and drug administration.I feel that mr.(b)(4) is unaware of the safety issues, which are caused through the proper use of the irestore laser helmet.I used the helmet exactly as directed and i read the instruction manual several times to ensure that i was using the irestore laser helmet correctly.Although i used the irestore laser helmet as instructed i still suffered physical harm as many others have.As noted earlier some of the customers from the (b)(6) website stated that the irestore helmet created greater hair loss, severe headaches, itchy scalp, unbearable pain, eye irritation, sleeplessness due to headaches, rash, scalp damage, scalp pain, inner ear pain, as well as many other serious side effects.The first time that i spoke with mr.(b)(4) on the telephone he sounded very sincere when he stated that freedom laser therapy takes complaints such as mine very seriously.I feel that all complaints in regards to the irestore laser helmet should be viewed as a legitimate complaint if it is made through the (b)(6) website, through freedom laser therapy¿s website, or through the (b)(6).I feel that mr.(b)(4) and freedom laser therapy should recognize all complaints, not exclusively the formal complaints that are made through the fda and disregard other complaints.As stated earlier, although mr.(b)(4) and i discussed a settlement agreement which i am declining, the main reason why i filed a complaint with the (b)(6) and currently with the fda is to warn current as well as potential freedom laser therapy clients in regards to health issues as well as permanent hair loss that could result from the use of the irestore laser helmet.I would like to request that the fda re-evaluate the safety of the irestore laser helmet, the accuracy of the statements made on freedom laser therapy¿s website (www.Irestorelaser.Com), and if freedom laser therapy¿s fda clearance should be revoked due to the harm that the devise has caused its clients.
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