Lumenis Stellar M22

The Lumenis Stellar M22 is a modular console that runs intense pulsed light and three laser handpieces from one base unit. It replaced the original M22, which served as its predicate when the FDA cleared the Stellar M22 under K193500 on January 16, 2020. In 2021 the FDA granted a De Novo request, DEN200028, that created a new device classification for IPL in dry eye. It covers IPL applied from tragus to tragus in adults with dry eye disease due to meibomian gland dysfunction.

The clearance describes four handpieces. The Stellar IPL handpiece covers 400 to 1200 nm and takes nine filters: cutoffs at 515, 560, 590, 615, 640, 695 and 755 nm, plus acne and vascular notch filters, with three sapphire lightguides. The Multi-Spot Nd:YAG handpiece works at 1064 nm with 2 x 4 mm, 6 mm and 9 mm lightguides. The ResurFX handpiece is a 1565 nm erbium glass fiber laser with SapphireCool and Precision tips. The Q-Switched Nd:YAG handpiece also runs at 1064 nm, and it accepts both disposable and gold plated metal tips in seven sizes from 2 to 8 mm.

The 510(k) comparison table lists a 12 inch display on the Stellar against 8.4 inches on the M22, and Windows 10 Embedded in place of Windows CE 5. The Stellar IPL also drops the KTP narrow band filter, the Nd:YAG handpiece loses its 1.5 mm tip, and the system now recognizes which lightguide is attached.

Because each handpiece adds a capability, list exactly which of the four came with your console and which are missing. Dealers want an inventory of IPL filters and lightguides, the condition of every sapphire surface, how many Q-switched tips remain, the software version shown on screen and the service record. Clear photos of the serial label, the main screen and each handpiece let a buyer confirm the configuration before quoting.