NIRA PRO 151-000Recalls & reported problems
Nira Innovations Incorporated · The NIRA PRO is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA PRO consists of a hand piece, wall-plug battery charger, and 1.5 foot USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a USB C connector interface that provides battery charging. The NIRA PRO is used for treatment of periorbital wrinkles. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850020752119), received between Jun 14, 2025 and Jun 14, 2025 — classified as 1 injury.
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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pain1
- Physical Asymmetry1
- Skin Discoloration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024, PATIENT, A 76-YEAR-OLD WOMAN, EXPERIENCED A SEVERE ADVERSE REACTION UPON WAKING UP THAT DAY. SHE WOKE UP TO FIND HER FACE SIGNIFICANTLY DISTORTED, WITH LUMPS, DARK AREAS, AND SWELLING. THE INTERNAL INFLAMMATION WAS SO SEVERE THAT IT MADE FLOSSING HER TEETH DIFFICULT DUE TO THE SWELLING INSIDE HER MOUTH. SHE HAD BEEN USING THE NIRA PRO DEVICE INTERMITTENTLY FOR THREE MONTHS. DESPITE HER CAREFUL USE, SHE DID NOT NOTICE ANY CHANGES UNTIL THE MORNING OF (B)(6) 2024, WHEN THE ADVERSE SYMPTOMS APPEARED SUDDENLY. SHE CLAIMS THAT THIS INFLAMMATION MAY BE THE RESULT OF THE NIRA LASER USE, HOWEVER THERE WAS NO DIRECT CONNECTION BETWEEN USING THE LASER FOR MANY MONTHS AND THIS PARTICULAR OVERNIGHT REACTION. IN AN ATTEMPT TO ADDRESS THE ISSUE, SHE VISITED HER DERMATOLOGIST, DR. (B)(6), ON (B)(6) 2024. DUE TO HER MEDICAL HISTORY, WHICH INCLUDES A PREVIOUS PERFORATED ULCER THAT PREVENTS HER FROM TAKING ANTI-INFLAMMATORIES, SHE WAS PRESCRIBED DOXYCYCLINE (100 MG, TWICE A DAY) AND OPZELURA CREAM. THE TREATMENT HAS LED TO SOME IMPROVEMENT, BUT AS OF (B)(6) 2024, SHE STILL EXPERIENCES SOME SWELLING AND BULGES ON HER FACE.
Patient problems: Pain; Physical Asymmetry; Skin Discoloration
MAUDE report 22208421 ↗
Other Light Based Over The Counter Wrinkle Reduction devices
- Shark CryoGlow FW312SharkNinja Operating LLC · Light Based Over The Counter Wrinkle Reduction2 reports
- NIRA Pro+ 174-000Nira Innovations Incorporated · Light Based Over The Counter Wrinkle Reduction1 report
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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