Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIRA INNOVATIONS INC. NIRA ANTI-AGING LASER DEVICE; LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NIRA INNOVATIONS INC. NIRA ANTI-AGING LASER DEVICE; LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION Back to Search Results
Health Effect - Clinical Codes Bruise/Contusion (1754); Skin Discoloration (2074); Skin Erosion (2075)
Type of Reportable Event Serious Injury
Event or Problem Description
I bought a nira device.This is hand-held device that is used to help with wrinkles.Approved to be used under the eyes at the time.Not sure about now.I used the device in 2022.After a few weeks of use under my eyes.I noticed that had a tremendous fat loss under my eyes and my eyes looked bruised.After two years the discoloration did not go away.Also, i used the device on other areas of my face.But it caused fat loss on the areas treated.For example, i treated a chicken pox scar with the device.After a few weeks i noticed difference in unevenness between areas treated and non-treated.This is a terrible device.You might not notice the damage right away.Until you wake up one day and you see a very drastic change on your skin.Do not get this product.Wrinkles (face).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NIRA ANTI-AGING LASER DEVICE
Common Device Name
LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
Manufacturer (Section D)
NIRA INNOVATIONS INC.
MDR Report Key20586460
Report NumberMW5161997
Device Sequence Number8346391
Product Code OHS
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Unknown
Type of Report Initial
Report Date (Section B) 10/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/31/2024
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
OMEGA 3.; TURMERIC.
Patient Age52 YR
Patient SexFemale
Patient Weight67 KG
Patient EthnicityHispanic
Patient RaceWhite
-
-