Skip to content

Photonica Professional 60001Recalls & reported problems

Photonica USA, LLC · Photonica Professional, Red Light (635 nm) · 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 00860925000307), received between Jun 5, 2019 and Nov 22, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device 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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Use of Device Problem1

Patient problems

  • Partial thickness (Second Degree) Burn1
  • Superficial (First Degree) Burn1

Recent adverse event reports

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

  • InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    RECEIVED THIRD PERSON VERBAL REPORT OF A PATIENT WHO ALLEGEDLY WAS BURNED DURING TREATMENT.

    Patient problems: Superficial (First Degree) Burn

    MAUDE report 15847882 ↗
  • InjuryJun 5, 2019Use of Device Problem; Use of Device Problem

    PATIENT CLAIMS TO HAVE BEEN BURNED DURING TREATMENT.

    Patient problems: Partial thickness (Second Degree) Burn

    MAUDE report 8670519 ↗

Other Fat Reducing Low Level Laser devices

All Fat Reducing Low Level Laser devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page