Lumenis M22

The Lumenis M22 is a multi-application console that runs intense pulsed light and laser handpieces from one base. In its 2013 ResurFX filing, Lumenis identified the M22 as the LUM 2 mainframe, which the FDA cleared under K083733 in May 2009 as the LUME 2 System. By the time of the January 2015 clearance, K142860, the M22 had four handpieces: Universal IPL, Multi-Spot Nd:YAG, ResurFX and Q-Switched Nd:YAG.

A 2017 special 510(k), K170060, lists the accessories for each handpiece. The Universal IPL covers 400 to 1200 nm with ten filters: cutoffs at 515, 560, 590, 615, 640, 695 and 755 nm, two notch filters and a 525 to 585 nm narrow band filter. The Multi-Spot Nd:YAG at 1064 nm takes 2 x 4 mm, 6 mm, 9 mm and 1.5 mm tips. The Q-Switched Nd:YAG accepts disposable tips from 2 to 5 mm and gold plated metal tips from 2 to 8 mm. ResurFX is a separate 1565 nm module, made up of a fiber laser, scanner, power supply and cooling unit, that adds onto the M22 mainframe.

The successor, the Stellar M22, lists the M22 as its predicate, and the 510(k) comparison gives clear signs for telling them apart. The M22 has an 8.4 inch screen running Windows CE 5, while the Stellar has a 12 inch screen and Windows 10 Embedded. The M22 IPL takes the KTP narrow band filter and the Nd:YAG handpiece takes a 1.5 mm tip, and the Stellar dropped both.

When you describe an M22, say whether the ResurFX module is installed, since it sits inside the system. Then list each handpiece, every IPL filter and lightguide, and any Q-switched tips. A dealer will ask about service history, sapphire condition and the software version. Photos of the serial label, the start screen and each handpiece help a buyer price it correctly.