510(k) Report

Devices descending from DEN090008

21 later devices reach Erchonia ML Scanner (MLS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160880Photonica ProfessionalWard Photonics, LLC20166—
+1K111501I-Lipo SystemChromogenex Technologies Limited201215—
+2K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+2K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+2K192275invisa-RED ELITEIR Technology, LLC20201—
+2K180338CellulizeWard Photonics, LLC20182—
+2K172111Vevazz LEDVevazz, LLC20170—
+2K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+2K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+3K213534PHantom TrilogyResurgeonz, LLC20220—
+3K202955Contour Light CL-100Contour Research, LLC20218—
+3K170709CURVE Laser SystemYolo Medical, Inc.20170—
+3K134040BTL-9000; BTL-9000 Radiofrequency ModuleBtl Industries, Ltd.20140—
+4K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+4K243854Contour Light (CL-100)Contour Research, LLC20261—
+4K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+4K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+5K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+5K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+5K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+6K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—