OLP · Class II · 21 CFR 878.4810

FDA Product Code OLP: Over-the-counter Powered Light Based Laser For Acne

The Device Is Intended For Over-the-counter (otc) Use To Treat Patients With Mild To Moderate Acne Vulgaris. The Device Is Intended To Emit Energy In The Red And Blue Region Of The Spectrum, Specifically Indicated To Treat Mild To Moderate Acne Vulgaris.

Leading manufacturers include Led Technologies, Inc., Shenzhen Kaiyan Medical CO , Ltd. and Harpar Grace International.

51
Total
51
Cleared
181d
Avg days
2009
Since
Stable submission activity - 4 submissions in the last 2 years
Review times improving: avg 130d recently vs 186d historically

FDA 510(k) Cleared Over-the-counter Powered Light Based Laser For Acne Devices (Product Code OLP)

51 devices
1–24 of 51
Cleared Mar 04, 2026
LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)
K253878
Shenzhen Kaiyan Medical Equipment Co., Ltd.
General & Plastic Surgery · 90d
Cleared Sep 12, 2025
Erchonia EVRL
K251843
Erchonia Corporation
General & Plastic Surgery · 88d
Cleared Apr 04, 2025
LED Light Therapy Mask (RT01)
K242068
Ningbo Dechang Electrical Machinery Made Co.,Ltd
General & Plastic Surgery · 263d
Cleared Feb 05, 2025
LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)
K243555
Shenzhen Eyco Technology Co., Ltd.
General & Plastic Surgery · 79d
Cleared Nov 14, 2023
BLU TOTALE (Model: ENEOB852)
K232656
Premier North America, Inc.
General & Plastic Surgery · 75d
Cleared Oct 27, 2023
PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT
K230490
Dongguan Hunter Electronic Technology Co., Ltd.
General & Plastic Surgery · 246d
Cleared Jul 03, 2023
LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001
K230720
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 109d
Cleared Jul 07, 2022
LED Facial Mask
K213056
Shenzhen Osto Technology Company Limited
General & Plastic Surgery · 288d
Cleared Jun 09, 2022
The Luminance RED Acne Device
K220729
Luminance Medical Ventures, Inc.
General & Plastic Surgery · 87d
Cleared May 25, 2022
Micro-current facial cold and hot service (model: TPML-100)
K213039
Li-Tek Electronics Technology C0., Ltd.
General & Plastic Surgery · 245d
Cleared May 20, 2022
Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine
K210545
Marci Beauty, Inc.
General & Plastic Surgery · 449d
Cleared Mar 22, 2022
Shani Darden LED light therapy mask
K214103
Harpar Grace International
General & Plastic Surgery · 83d
Cleared Dec 21, 2021
reVive Light Therapy Essentials
K210968
Led Technologies, Inc.
General & Plastic Surgery · 265d
Cleared Nov 23, 2021
MZ Skin LightMAX Supercharged LED Mask 2.0
K213184
Mz Skin
General & Plastic Surgery · 55d
Cleared Jul 22, 2021
DemarkQ WOW, DemarkQ POP
K203214
Shenzhen Kaiyan Medical CO , Ltd.
General & Plastic Surgery · 262d
Cleared Jul 21, 2021
Aduro light therapy Handheld
K203271
Shenzhen Kaiyan Medical CO , Ltd.
General & Plastic Surgery · 257d
Cleared Jun 24, 2021
Omnilux CLEAR
K210948
Globalmed Technologies
General & Plastic Surgery · 86d
Cleared Apr 16, 2021
Looper (Model: ZX-579S)
K202055
Heat IN A Click, LLC
General & Plastic Surgery · 266d
Cleared May 01, 2020
PDT-FACE
K192295
Beijing Adss Development Co., Ltd.
General & Plastic Surgery · 252d
Cleared Sep 17, 2019
Poly Clear
K183708
Medtek Skincare, LLC
General & Plastic Surgery · 260d
Cleared Feb 07, 2019
dpl SpotLite
K183118
Led Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Aug 30, 2018
LYFT
K180888
Uplevity, Inc.
General & Plastic Surgery · 148d
Cleared Jul 10, 2018
LED Light Therapy Device
K180900
Uvbiotek, LLC
General & Plastic Surgery · 95d
Cleared Jun 19, 2018
Neutrogena Light Therapy Acne Mask+
K180847
Johnson & Johnson Consumer, Inc.
General & Plastic Surgery · 78d

About Product Code OLP - Regulatory Context

510(k) Submission Activity

51 total 510(k) submissions under product code OLP since 2009, with 51 receiving FDA clearance (average review time: 181 days).

Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.

FDA 510(k) Review Time - OLP Product Code

Recent submissions under OLP have taken an average of 130 days to reach a decision - down from 186 days historically, suggesting improved FDA processing for this classification.

OLP devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →