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NIRA Bundle (Pro Gen 3, White)

Nira Innovations Incorporated · Model 181-000-C01 · UDI-DI 00850020752263

OHS

510(k) clearances

107

Adverse events

Recalls

133

Facilities

Description

The NIRA Laser Bundle is a set of hand-held reusable OTC non-fractional diode laser devices employing 1450 nm wavelength. The NIRA Lasesr consists of a 2 hand pieces, wall charger and 1.5 foot USB cable. The hand pieces fits in the hand and the laser light comes out of the tip. There is a single USB C connector interface that provides battery charging. The NIRA Lasers is used for treatment of periorbital wrinkles.

Recalls

Date	Firm	Reason
2018-06-29	Quasar Bio-Tech, Inc.	Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
2018-06-29	Quasar Bio-Tech, Inc.	Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
2018-06-29	Quasar Bio-Tech, Inc.	Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
2008-06-18	Sybaritic, Inc	Sybaritic stated that no 510(k) has been filed for the device (Lumi 8 Intense LED Light Facial System). No injuries or illness reported.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.