Light Based Over The Counter Wrinkle Reduction
FDA product code OHS · 154 cleared devices
Class 2
General, Plastic Surgery
- Regulation
- 21 CFR 878.4810
- Review panel
- SU
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2008-02-15 – 2026-08-31
Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.
OHS
2026-08-31
OHS
2026-08-10
Eye Recovery Pro (PH-e03)
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OHS
2026-08-07
LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)
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OHS
2026-08-04
LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)
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OHS
2026-08-04
LED Light Therapy Masks (PE748, PE749, PE756)
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OHS
2026-07-31
LightStim for Wrinkles (1984); LightStim for Acne (2038)
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OHS
2026-07-24
5 Wavelength LED Facemask (TN2508)
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OHS
2026-07-15
XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445)
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OHS
2026-07-01
Chromix
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OHS
2026-06-29
LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)
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OHS
2026-06-18
LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)
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OHS
2026-06-16
LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)
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OHS
2026-06-03
CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)
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OHS
2026-05-12
myLEDmask 2 (MJ-144)
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OHS
2026-04-22
LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)
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OHS
2026-03-23
LED Light Therapy Masks (LumiLips FAC07NA)
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OHS
2026-03-16
Ulike Reglow Light Therapy Device (UM10)
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OHS
2026-03-16
LED Light Therapy Mask (Models: T2, RLD10)
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OHS
2026-03-03
LED Therapy Light (COB1400, HP1800PRO)
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OHS
2026-02-20
FAQ™ (LED Panel); FAQ™ (Dual LED Panel)
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OHS
2026-02-12
LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)
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OHS
2026-01-30
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)
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OHS
2026-01-28
HIGHERDOSE Body Sculptor (Model: GS-03)
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OHS
2026-01-23
LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)
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OHS
2025-12-24
LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)
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OHS
2025-12-24
Feather/numiere 05 06 07 (05)
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OHS
2025-12-23
LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.)
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OHS
2025-12-19
LED Light Therapy Device (Models: SG-FM, SG-FE)
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OHS
2025-12-19
LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)
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OHS
2025-12-17
Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)
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OHS
2025-12-08
LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)
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OHS
2025-12-05
Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
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OHS
2025-11-19
LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)
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OHS
2025-11-19
Microcurrent Facial Device (CEC101, EEI101)
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OHS
2025-11-13
LED Beauty Mask (RLBXX)
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OHS
2025-10-27
VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)
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OHS
2025-10-17
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)
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OHS
2025-10-16
Light Therapy Mask (1019055)
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OHS
2025-10-09
ORA Method LED Gua Sha (GS-04)
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OHS
2025-10-01
Light Therapy Decollete Mask (1019135)
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OHS
2025-10-01
Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)
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OHS
2025-09-12
LED Light Therapy Mask (2311, 2344, 2457, 2458)
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OHS
2025-09-04
KALA MINI 2.0 (KALA-04)
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OHS
2025-08-21
LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)
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OHS
2025-08-15
FEATHER 01 02 03 04 (Model:01)
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OHS
2025-08-14
TRUDERMAL Pro (ZLD-390)
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OHS
2025-08-07
LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)
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OHS
2025-07-11
KALA Therapy Wand (Model: KALA-03)
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OHS
2025-06-25
CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)
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OHS
2025-06-20
LED LIGHT MASK (A093)
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OHS
2025-06-20
LED Facial Mask
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OHS
2025-06-09
LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)
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OHS
2025-06-06
Light Therapy System (M500, L6)
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OHS
2025-05-30
KALA Red Light Face Mask (KALA-01)
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OHS
2025-05-22
Solawave 2-in-1 Skincare Mini (Model: 61043)
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OHS
2025-05-01
Wrinkle Treatment Device (JM1, JM2B)
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OHS
2025-04-08
Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)
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OHS
2025-04-07
LED Therapy Mask (MN1, M226)
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OHS
2025-03-24
LMNT O2
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OHS
2025-03-18
Aglaia LED Beauty Device (BP-D2309)
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OHS
2025-03-03
EnergyLounger (TY-01)
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OHS
2025-02-21
LYMA Laser PRO
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OHS
2025-02-14
CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)
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OHS
2025-01-28
LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB)
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OHS
2025-01-10
Ulike Reglow Light Therapy Device (UM10)
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OHS
2025-01-02
Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)
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OHS
2024-12-20
LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)
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OHS
2024-12-19
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)
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OHS
2024-11-27
CryoGlow (FW3XXXX)
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OHS
2024-11-27
LED Light Therapy Machine (G1, G3, G4, G6)
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OHS
2024-11-08
décoLITE LED Device
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OHS
2024-10-28
Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
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OHS
2024-10-11
LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)
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OHS
2024-09-27
HIGHERDOSE Red and Infrared Light Mask (MK66-L)
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OHS
2024-08-20
Luna 4 plus
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OHS
2024-07-25
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)
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OHS
2024-04-19
FAQ™ 201, FAQ™ 202
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OHS
2024-04-10
Face Patches (MT-12MA, MT-12MC)
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OHS
2024-04-05
Wrinkle Treatment Device (JM2)
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OHS
2024-03-01
NUNA LUX (NUNL528)
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OHS
2024-01-12
LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)
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OHS
2024-01-04
LED Eye mask (EY-20R, A20, EY-20N)
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OHS
2023-12-13
Radiant Renewal Skincare Wand (HD-15, HD-15A)
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OHS
2023-12-07
Led Mask Platinum Exclusive MD
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OHS
2023-09-23
B.Light Clear Evo and B.Light Restore Evo
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OHS
2023-07-27
LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))
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OHS
2023-06-09
TheraFace Mask
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OHS
2023-05-16
Infrared Heat (Model: E0221)
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OHS
2023-05-14
myLEDmask
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OHS
2023-05-05
LED Facial Mask
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OHS
2023-04-28
Q-Rejuvalight Pro Facewear (Model: P19-0023)
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OHS
2023-03-15
LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)
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OHS
2023-02-23
LED light therapy mask (FM-01, FM-02, FM-03)
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OHS
2023-02-08
NIRA Model 2
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OHS
2022-12-21
reVive Light Therapy® Wrinkle and Acne LED Device
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OHS
2022-12-20
LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)
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OHS
2022-12-08
LED Eye Perfector, model: EY-36A, EY-36B
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OHS
2022-11-22
LED Light Therapy Mask (model: MK66R-B)
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OHS
2022-11-17
easy Claire
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OHS
2022-11-03
Led Mask Platinum Md
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