510(k) Report

Devices descending from K062991

22 later devices reach Gentlewaves Consumer Led Photomodulation Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+1K090525Loi SystemPalomar Medical Products, Inc.20099—
+2K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+2K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+2K130459Tria Fan SystemTria Beauty, Inc.20131—
+2K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+2K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+3K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+3K230077LaserMENeauvia North America20232—
+3K222685NIRA Model 2Dermal Photonics Corp20230—
+3K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+3K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+3K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+3K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+3K141868Tria FanpTria Beauty, Inc.20140—
+4K261473ChromixTermosalud S.L.20260—
+4K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+4K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+4K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—