510(k) Report

Devices descending from K083203

6 later devices reach Helios II Q-Switched ND:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152856Helios IIILaseroptek Co., Ltd.20165—
+2K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+2K212663Helios IV 785Laseroptek Co., Ltd.20223—
+3K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+4K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+4K240752Deka ToroEl.En S.P.A.20240—