510(k) Report

Devices descending from K081962

19 later devices reach Lapex BCS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110342Yolo CurveYolo Medical, Inc.20110—
+1K102375LUCIAMeridian Co., Ltd.20111—
+1K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+2K111501I-Lipo SystemChromogenex Technologies Limited201215—
+3K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+3K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+4K213534PHantom TrilogyResurgeonz, LLC20220—
+4K202955Contour Light CL-100Contour Research, LLC20218—
+4K192275invisa-RED ELITEIR Technology, LLC20201—
+4K170709CURVE Laser SystemYolo Medical, Inc.20170—
+4K134040BTL-9000; BTL-9000 Radiofrequency ModuleBtl Industries, Ltd.20140—
+5K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+5K243854Contour Light (CL-100)Contour Research, LLC20261—
+5K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+5K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+6K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+6K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+6K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+7K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—