BEUDAMED
    Product Code: OHS FDA class 2 21 CFR 878.4810

    Light Based Over The Counter Wrinkle Reduction

    General, Plastic Surgery

    The Light Based Over The Counter Wrinkle Reduction device uses light-based energy to reduce wrinkles on the body or specific anatomical locations, intended for consumer self-use without a prescription. Classified as FDA Class 2 under regulation 21 CFR 878.4810 within the General, Plastic Surgery medical specialty, it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is OHS. It is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    153
    FEI Numbers
    126
    Registration Numbers
    126
    Unique Applicants
    96
    Years Active
    18

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    Basic Information

    Product Code
    OHS
    Device Class
    FDA class 2
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 153 510(k) clearances via K numbers.

    K Number Device Name
    K260946 LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)
    K254025 LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)
    K260715 CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)
    K260415 myLEDmask 2 (MJ-144)
    K260150 LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)
    K260202 LED Light Therapy Masks (LumiLips FAC07NA)
    K260511 Ulike Reglow Light Therapy Device (UM10)
    K254079 LED Light Therapy Mask (Models: T2, RLD10)
    K253874 LED Therapy Light (COB1400, HP1800PRO)
    K253683 FAQ™ (LED Panel); FAQ™ (Dual LED Panel)
    K254007 LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)
    K253833 Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)
    K252603 HIGHERDOSE Body Sculptor (Model: GS-03)
    K253712 LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)
    K253400 LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)
    K253279 Feather/numiere 05 06 07 (05)
    K253135 LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.)
    K253086 LED Light Therapy Device (Models: SG-FM, SG-FE)
    K253054 LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)
    K252983 Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)
    K252994 LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)
    K252142 Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
    K253073 LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)
    K252642 Microcurrent Facial Device (CEC101, EEI101)
    K252308 LED Beauty Mask (RLBXX)
    K252053 VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)
    K252264 MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10)
    K252093 Light Therapy Mask (1019055)
    K252272 ORA Method LED Gua Sha (GS-04)
    K252096 Light Therapy Decollete Mask (1019135)
    K251825 Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)
    K252189 LED Light Therapy Mask (2311, 2344, 2457, 2458)
    K251781 KALA MINI 2.0 (KALA-04)
    K251588 LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)
    K251871 FEATHER 01 02 03 04 (Model:01)
    K251012 TRUDERMAL Pro (ZLD-390)
    K251667 LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)
    K250761 KALA Therapy Wand (Model: KALA-03)
    K250966 CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)
    K250880 LED LIGHT MASK (A093)
    K243978 LED Facial Mask
    K250830 LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)
    K251042 Light Therapy System (M500, L6)
    K250581 KALA Red Light Face Mask (KALA-01)
    K250532 Solawave 2-in-1 Skincare Mini (Model: 61043)
    K244020 Wrinkle Treatment Device (JM1, JM2B)
    K242151 Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)
    K242385 LED Therapy Mask (MN1, M226)
    K250125 LMNT O2
    K250413 Aglaia LED Beauty Device (BP-D2309)
    K241947 EnergyLounger (TY-01)
    K243330 LYMA Laser PRO
    K242593 CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)
    K243423 LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB)
    K243492 Ulike Reglow Light Therapy Device (UM10)
    K242789 Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)
    K243040 LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)
    K242700 Radiant 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-53A, HD-53B)
    K242796 CryoGlow (FW3XXXX)
    K242638 LED Light Therapy Machine (G1, G3, G4, G6)
    K242382 décoLITE LED Device
    K241718 Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
    K241857 LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)
    K241933 HIGHERDOSE Red and Infrared Light Mask (MK66-L)
    K241102 Luna 4 plus
    K241203 PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT)
    K240378 FAQ™ 201, FAQ™ 202
    K240089 Face Patches (MT-12MA, MT-12MC)
    K240360 Wrinkle Treatment Device (JM2)
    K233862 NUNA LUX (NUNL528)
    K233114 LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)
    K233556 LED Eye mask (EY-20R, A20, EY-20N)
    K232863 Radiant Renewal Skincare Wand (HD-15, HD-15A)
    K232795 Led Mask Platinum Exclusive MD
    K223919 B.Light Clear Evo and B.Light Restore Evo
    K231555 LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))
    K230293 TheraFace Mask
    K223893 Infrared Heat (Model: E0221)
    K223147 myLEDmask
    K230351 LED Facial Mask
    K230042 Q-Rejuvalight Pro Facewear (Model: P19-0023)
    K230124 LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)
    K223544 LED light therapy mask (FM-01, FM-02, FM-03)
    K222685 NIRA Model 2
    K223482 reVive Light Therapy® Wrinkle and Acne LED Device
    K221775 LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)
    K221444 LED Eye Perfector, model: EY-36A, EY-36B
    K221946 LED Light Therapy Mask (model: MK66R-B)
    K223278 easy Claire
    K222377 Led Mask Platinum Md
    K221430 reVive Light Therapy LED Cleansing System
    K220064 Synergy Marble (Model: Opasm)
    K221151 Beauty LED Mask, Model: KFB265
    K220168 Skin Care Beauty Mask (Model: MJ-06)
    K212947 Trinity Plus Wrinkle Reducer
    K214101 Project E Beauty LED Light Therapy Mask (Model: PE730)
    K210823 LYMA Laser
    K213285 easy Claire
    K212771 LightStim Elipsa
    K213841 ENEO TOTALE (Model: ENEOT947)
    K213024 Oren LED Perioral Light Therapy System
    K212155 TheraFace LED
    K210965 reVive Light Therapy Essentials
    K212275 Dermalux Flex MD
    K202390 Aduro Light Beauty Mask
    K200983 Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine
    K210954 Synergy
    K202442 Carewear Firefly Wrinkle Reduction
    K201107 Opera Lebody (Gold), Opera Lebody (Zafiro)
    K191629 faceLITE
    K190443 MMSphere
    K183247 dpl Faceware
    K183671 LG PRA.L DERMA LED MASK
    K180875 POLY REJUV
    K181659 Avologi ENEO
    K180856 Neutrogena Light Therapy Aging Mask+
    K172909 ELEVARE, PERFECTIO 4
    K180445 reVive Light Therapy LED Ultrasonic Wrinkle System
    K180320 dpl IIa Panel
    K172662 reVive Perioral
    K171323 BIOPHOTAS CELLUMA3
    K170984 LG BEAUTY LED MASK
    K171386 dpl SpectraLite
    K171390 dpl II Panel
    K163137 NIRA Beauty Skin Laser
    K163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72
    K162784 Silk'n HST
    K162489 RED Light Device
    K161849 Bright
    K152332 Perfectio LED infrared device
    K151337 Strialite
    K151336 LightStim Professional 2-Panel Light
    K150098 LightStim Professional 2-Panel Light
    K141181 NUVE FOR WRINKLES, DPL NUVE FOR WRINKLES
    K140471 PRO X OTC 5
    K133896 REJUVALITE MD
    K141308 NUTRA LIGHT RED
    K133546 STARLITE-OM, LIGHT EFFECTS, THIBIANT
    K132613 SONILASE LIGHT THERAPY DEVICE
    K133473 ILUMINAGE SKIN SMOOTHING LASER
    K124064 YOUNG AGAIN
    K130225 QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE
    K120560 TRINITY WRINKLE REMOVER
    K112362 C100 WRINKLE REDUCTION DEVICE
    K111454 ILUMINAGE DIODE LASER
    K120775 LIGHT FOR WRINKLES
    K110301 SILK'N FX
    K110735 TANDA MAX OTC SYSTEM
    K101382 DPL NUVE
    K101190 LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC
    K092460 STAR-LITE -LM, MODEL SL8809
    K072459 OMNILUX NEW-U
    K062991 GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE

    FEI Numbers

    This FDA classification entry is associated with 126 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 126 registration numbers. Click on an entry to view related FDA registrations.