MAUDE Adverse Event Report: SHENZHEN IONKA MEDICAL TECHNOLOGY CO., LTD. HOME LASER HAIR REMOVAL DEVICE; LIGHT BASED OVER-THE-COUNTER HAIR REMOVAL

Medical Device Problem Codes	Nonstandard Device (1420); Off-Label Use (1494); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Death
Event or Problem Description
Formal complaint against "ubroo" home laser hair removal device: i am a dedicated skincare enthusiast with a focus on consumer rights, writing to formally report serious regulatory violations by ubroo regarding its "ubroo home hair remover machine /hand-hled hair removal device", sold on amazon platform (https://www.Amazon.Com/dp/b0d172grnq/ref=twister_b0drjjtqdc?_encoding=utf8&th=1) and its dtc website (https://ubrooskin.Com/products/laser-hair-removal-with-5-ice-cooling-painless-ipl-laser-hair-removal-device-3-in-1-ubroo-at-home-hair-remover-machine-for-women-men-electrolysis-permanent-epilator-on-face-body-depilation-gold).My complaints include "unlawful marketing of an unregistered class ii medical device, false advertising, and dangerous misbranding", detailed below with legal citations and evidence.Unregistered class ii medical device (fda 510(k) violation) the "ubroo" device is marketed as a "ipl hair removal device", which is classified as a class ii medical device by fda.Despite this, no 510(k) premarket notification is listed in fda's database for this product and no fda establishment registration of manufacturer.Misbranding & inadequate labeling the device's labeling violates fda's requirements for "transparency and safety": missing manufacturer information: the device, packaging, and user manual lack the "name/address of the manufacturer/distributor", violating 21 cfr 801.1(a).- incomplete instructions for use: - no contraindications (e.G., for darker skin tones or epilepsy) are listed, violating 21 cfr 801.109(c).- no emc (electromagnetic compatibility) compliance information is provided, a critical safety standard for medical devices (*iec 60601-1-2*, adopted by fda).Contradictory technology claims & radiation safety violations the product packaging and manual contain conflicting technology descriptions, creating material misrepresentation: ipl vs.Laser misbranding: the packaging states "ipl technology," but the manual claims "laser hair removal." these are distinct technologies: - ipl (intense pulsed light): a non-laser device, typically regulated as a class ii device.- laser: a class ii medical device requiring 510(k) clearance and radiation safety compliance (21 cfr 1040.10).- if the device is ipl but marketed as "laser," this violates ftc act § 5 (deceptive advertising).If it is truly a laser, the lack of 510(k) registration violates fd&c act § 510(k).- unsubstantiated laser claims: - the manual's "laser" labeling lacks fda-mandated radiation safety disclosures, including: - laser class designation (e.G., class iiib) per 21 cfr 1040.10(g).- wavelength, power output, and warning statements (e.G., "danger: eye hazard") per 21 cfr 1040.10(e).- missing radiation safety report: unlawful medical device misbranding & unapproved therapeutic claims ubroo's amazon and dtc listing and product materials contain unsubstantiated medical claims that violate fda's premarket approval requirements and labeling regulations.- unauthorized medical device marketing: the device is marketed with therapeutic claims exceeding the scope of a general consumer product: - painless treatment: the claim "painless" constitutes a medical efficacy statement requiring fda classification as a class ii device.- temperature control: the "keeps skin below 5°c" claim relates to thermal safety, a critical parameter for medical devices.- smooth skin claims: statements like "75% hair reduction after 4 weeks", "smooth skin after 8 weeks", and "92.4% of women reported 96% hair reduction after 2 months" constitute medical device claims that may only be made after obtaining 510(k) clearance as a class ii device under 21 cfr 807.20(a) and 21 cfr 801.1.5.Request for action - enforce 510(k) registration: remove "ubroo" from the market until 510(k) clearance and establishment registration are confirmed.Information about manufacturers and seller since the manufacturer information for this product is completely untraceable, the only contact details that can be found are in the instruction manual: phone: (b)(6).- products s/n: (b)(6).- the seller marked as 'hounytry' on the amazon website, which is shenzhen zehongyuan technology co., ltd.Registered address is: building 69, aotou new village, shangfen community, minzhi street, longhua district, shenzhen, china.

• Brand Name: HOME LASER HAIR REMOVAL DEVICE
• Common Device Name: LIGHT BASED OVER-THE-COUNTER HAIR REMOVAL
• Manufacturer (Section D): SHENZHEN IONKA MEDICAL TECHNOLOGY CO., LTD.
• MDR Report Key: 22338159
• Report Number: MW5171942
• Device Sequence Number: 8417551
• Product Code: OHT
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 06/12/2025

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
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Sex: Male