Lumecca 515 AS601863ARecalls & reported problems

Inmode M.D Ltd · Lumecca 515 · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290016633108), received between Apr 27, 2023 and Apr 24, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Electrical /Electronic Property Problem1
Use of Device Problem1

Patient problems

Full thickness (Third Degree) Burn1
Scar Tissue1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryApr 24, 2025Use of Device Problem; Use of Device Problem
SCARRING ON NOSE AND DÉCOLLETÉ FOLLOWING LUMECCA TREATMENT.
Patient problems: Scar Tissue
MAUDE report 21897600 ↗
InjuryApr 27, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
A FULL THICKNESS BURN (3RD DEGREE) OF RECTANGULAR SHAPE AND DIMENSIONS OF APPROXIMATELY 2 X 1 CM LOCATED IN THE CENTER OF RIGHT MALAR AREA FOLLOWING LUMECCA 515 TREATMENT.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 16821921 ↗

Device details

UDI-DI	`07290016633108`
Brand	Lumecca 515
Model	AS601863A
Company	Inmode M.D Ltd
Product code	ONF · Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Class	Class 2
FDA submission	K123860
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 3, 2023

Device type (GMDN): Multi-modality skin surface treatment system

An electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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