ClearanceBrief
Panels › General, Plastic Surgery › Product code OHS · Class 2

Light Based Over The Counter Wrinkle Reduction

Regulation 878.4810

37510(k)s in 12 months (165 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
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Top companies in OHS

Company510(k)sRecalls
Shenzhen Kaiyan Medical Equipment Co., Ltd.150
Led Technologies, Inc.110
Light Tree Ventures Europe B.V.70
Led Intellectual Properties, LLC60
Guangdong Newdermo Biotech Co., Ltd.40
Foreo, Inc.30
iSMART Developments, Ltd.30
Premier North America, Inc.30
Quasar Bio-Tech, Inc.03
Shenzhen Kaiyan Medical CO , Ltd.30
Decided510(k)Device and applicantCode
Jun 25, 2025K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)
Shenzhen Kaiyan Medical Equipment Co., Ltd., CN
OHS
Jun 20, 2025K250880LED LIGHT MASK (A093)
Foshan Guangyu Weilai Medical Equipment Co., Ltd., CN
OHS
Jun 20, 2025K243978LED Facial Mask
Shenzhen Sunsred Technology Co.,Ltd, CN
OHS
Jun 9, 2025K250830LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)
Shenzhen Sungrow Led Technology Co., Ltd., CN
OHS
Jun 6, 2025K251042Light Therapy System (M500, L6)
Guangzhou Ahead Intelligent Technology Co., Ltd., CN
OHS
May 30, 2025K250581KALA Red Light Face Mask (KALA-01)
Shenzhen Kaiyan Medical Equipment Co., Ltd., CN
OHS
May 22, 2025K250532Solawave 2-in-1 Skincare Mini (Model: 61043)
Shenzhen Kaiyan Medical Equipment Co., Ltd., CN
OHS
May 1, 2025K244020Wrinkle Treatment Device (JM1, JM2B)
Shenzhen Qianyu Technology Co., Ltd., CN
OHS
Apr 8, 2025K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)
Shenzhen Nuon Medical Equipment Co., Ltd., CN
OHS
Apr 7, 2025K242385LED Therapy Mask (MN1, M226)
Shenzhen Borria Technology Co., Ltd., CN
OHS
Mar 24, 2025K250125LMNT O2
Xplr , Ltd., IL
OHS
Mar 18, 2025K250413Aglaia LED Beauty Device (BP-D2309)
Shenzhen Perfect Idea Technology Limited, CN
OHS
Mar 3, 2025K241947EnergyLounger (TY-01)
Shenzhen Kaiyan Medical Equipment Co., Ltd., CN
OHS
Feb 21, 2025K243330LYMA Laser PRO
Lyma Life , Ltd., GB
OHS
Feb 14, 2025K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)
Shenzhen Kaiyan Medical Equipment Co., Ltd., CN
OHS
Jan 28, 2025K243423LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB)
Shenzhen Rainbow Technology Co., Ltd., CN
OHS
Jan 10, 2025K243492Ulike Reglow Light Therapy Device (UM10)
Shenzhen Ulike Smart Electronics Co., Ltd., CN
OHS
Jan 2, 2025K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)
Dongguan Laiguang Electronic Technology Co., Ltd., CN
OHS
Dec 20, 2024K243040LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)
Shenzhen Siken 3D Technology Development Co., Ltd., CN
OHS
Dec 19, 2024K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-
Shenzhen Nuon Medical Equipment Co., Ltd., CN
OHS
Nov 27, 2024K242796CryoGlow (FW3XXXX)
Sharkninja Operating, LLC
OHS
Nov 27, 2024K242638LED Light Therapy Machine (G1, G3, G4, G6)
Shenzhen Walton Technology Co., Ltd., CN
OHS
Nov 8, 2024K242382décoLITE LED Device
iSMART Developments, Ltd., GB
OHS
Oct 28, 2024K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
Shenzhen Aozemei Technology Co., Ltd., CN
OHS
Oct 11, 2024K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)
Dongguan Boyuan Intelligent Technology Co.,Ltd, CN
OHS
Sep 27, 2024K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)
Shenzhen Kaiyan Medical Equipment Co., Ltd., CN
OHS
Aug 20, 2024K241102Luna 4 plus
Foreo, Inc.
OHS
Jul 25, 2024K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005
Dongguan Hunter Electronic Technology Co., Ltd., CN
OHS
Apr 19, 2024K240378FAQ™ 201, FAQ™ 202
Foreo, Inc.
OHS
Apr 10, 2024K240089Face Patches (MT-12MA, MT-12MC)
Shenzhen Kaiyan Medical Equipment Co., Ltd., CN
OHS
Apr 5, 2024K240360Wrinkle Treatment Device (JM2)
Shenzhen Qianyu Technology Co., Ltd., CN
OHS
Mar 1, 2024K233862NUNA LUX (NUNL528)
Premier North America, Inc.
OHS
Jan 12, 2024K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)
Shenzhen Idea Light Limited, CN
OHS
Jan 4, 2024K233556LED Eye mask (EY-20R, A20, EY-20N)
Shenzhen Kaiyan Medical Equipment Co., Ltd., CN
OHS
Dec 13, 2023K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)
Shenzhen Kaiyan Medical Equipment Co., Ltd., CN
OHS
Dec 7, 2023K232795Led Mask Platinum Exclusive MD
Stg24 Co., Ltd., KR
OHS
Sep 23, 2023K223919B.Light Clear Evo and B.Light Restore Evo
Bemer Int AG, LI
OHS
Jul 27, 2023K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))
iSMART Developments, Ltd., GB
OHS
Jun 9, 2023K230293TheraFace Mask
Therabody, Inc.
OHS
May 16, 2023K223893Infrared Heat (Model: E0221)
Light Tree Ventures Europe B.V., NL
OHS
May 14, 2023K223147myLEDmask
Myblend, FR
OHS
May 5, 2023K230351LED Facial Mask
Shenzhen Sungpo Hi-Tech Electronic Co., Ltd., CN
OHS
Apr 28, 2023K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)
Light Tree Ventures Europe B.V., NL
OHS
Mar 15, 2023K230124LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)
Light Tree Ventures Europe B.V., NL
OHS
Feb 23, 2023K223544LED light therapy mask (FM-01, FM-02, FM-03)
Guangdong Newdermo Biotech Co., Ltd., CN
OHS
Feb 8, 2023K222685NIRA Model 2
Dermal Photonics Corp
OHS
Dec 21, 2022K223482reVive Light Therapy® Wrinkle and Acne LED Device
Led Technologies, Inc.
OHS
Dec 20, 2022K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)
Light Tree Ventures Europe B.V., NL
OHS
Dec 8, 2022K221444LED Eye Perfector, model: EY-36A, EY-36B
Light Tree Ventures Europe B.V., NL
OHS
Nov 22, 2022K221946LED Light Therapy Mask (model: MK66R-B)
Light Tree Ventures Europe B.V., NL
OHS

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