MAUDE Adverse Event Report: FOSHAN JINDI ELECTRIC APPLIANCE CO.,LTD INNZA IPL HAIR REMOVAL; LIGHT BASED OVER-THE-COUNTER HAIR REMOVAL

Model Number	JD-TM016
Medical Device Problem Codes	Nonstandard Device (1420); Off-Label Use (1494); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	08/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Device problems nonstandard device (1420); off-label use (1494); device markings/labeling problem (2911) patient problem severe thermal burns ¿ right thigh, likely second-degree icd-10 codes: t23.211a ¿ burn of right thigh, unspecified degree, initia event date august 18, 2025.Event type burn event description formal complaint regarding innza home laser hair removal device: i am a consumer concerned with skincare safety and regulatory compliance.I am submitting this formal complaint regarding innza and its "innza home hair remover machine / handheld hair removal device," sold on amazon and through its direct-to-consumer website.This complaint addresses the unlawful marketing of an unregistered class ii medical device, false advertising, and misbranding, detailed below with supporting legal references.1.Unregistered class ii medical device (fda 510(k) violation) the innza device is marketed as an "ipl hair removal device," but it is not registered with the fda and has no 510(k) clearance.According to fda classification, any device claiming the ability to destroy hair follicles to reduce hair growth qualifies as a class ii medical device.This means it must have fda approval to legally market such claims.The innza device lacks fda authorization yet publicly claims it can effectively destroy hair follicles, which constitutes illegal medical device marketing and presents a serious consumer safety risk.2.Misbranding and inadequate labeling the device fails to meet fda labeling and safety transparency requirements: missing manufacturer information: the device, packaging, and user manual do not provide the manufacturer or distributor's name and address, violating 21 cfr 801.1(a).Incomplete instructions for use: no contraindications are listed (e.G., for darker skin tones, pregnancy, or epilepsy), violating 21 cfr 801.109(c).No electromagnetic compatibility (emc) compliance information is provided, even though fda adopts iec 60601-1-2 as the standard for medical device safety.These omissions prevent consumers from using the device safely and constitute misbranding.3.Contradictory technology claims and radiation safety violations the device's packaging and manual contain inconsistent technical descriptions: ipl vs.Laser mislabeling: the packaging claims "ipl technology," while the manual refers to "laser hair removal." these are different technologies with different regulatory requirements: ipl (intense pulsed light): class ii medical device using filtered broad-spectrum light.Laser: class ii medical device requiring 510(k) clearance and compliance with radiation safety regulations (21 cfr 1040.10).Marketing ipl as "laser" is deceptive advertising under ftc act §5.If it is a true laser device, the lack of 510(k) clearance and radiation safety reporting violates fda regulations.Missing laser safety information: the manual does not include: laser classification (e.G., class iiib) -- required under 21 cfr 1040.10(g); wavelength, power output, and safety warnings (e.G., "danger: laser radiation -- avoid eye exposure") -- required under 21 cfr 1040.10(e).4.False and unapproved medical claims innza's promotional materials make unsubstantiated medical efficacy claims, misleading consumers: claims of hair follicle destruction: the product claims that "the light penetrates hair follicles to effectively destroy them and reduce hair regrowth." this is a medical claim implying permanent or long-term physiological effect on hair follicles.According to fda regulations, only fda-cleared class ii medical devices may make such claims.The innza device is not fda-cleared, making this a false and unlawful marketing claim.Other misleading efficacy claims: the product also claims: "up to 95.08% hair reduction in 3 weeks," "smooth skin after 8 weeks," "painless treatment," "keeps skin below 5°c for comfort." all of these con.

• Brand Name: INNZA IPL HAIR REMOVAL
• Common Device Name: LIGHT BASED OVER-THE-COUNTER HAIR REMOVAL
• Manufacturer (Section D): FOSHAN JINDI ELECTRIC APPLIANCE CO.,LTD
• MDR Report Key: 23258703
• Report Number: MW5177149
• Device Sequence Number: 5005853
• Product Code: OHT
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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): 10/06/2025

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
• Device Model Number: JD-TM016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability; Congenital Anomaly; Life Threatening; Hospitalization
• Patient Sex: Male
• Patient Race: American Indian Or Alaskan Native