Atlas FDA

OLP

51 FDA 510(k) clearances · Product code

159 daysmedian time to decision
280 days90th percentile
51clearances measured

FDA profile

Official device name
Over-The-Counter Powered Light Based Laser For Acne
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4810
Medical specialty
General, Plastic Surgery
FDA definition
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.
Adverse events (MAUDE)
2019: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) (K253878)Shenzhen Kaiyan Medical Equipment Co., Ltd.2026-03-04
Erchonia EVRL (K251843)Erchonia Corporation2025-09-12
LED Light Therapy Mask (RT01) (K242068)Ningbo Dechang Electrical Machinery Made Co.,Ltd2025-04-04
LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) (K243555)Shenzhen Eyco Technology Co., Ltd.2025-02-05
BLU TOTALE (Model: ENEOB852) (K232656)Premier North America, Inc.2023-11-14
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.2023-10-27
LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 (K230720)Light Tree Ventures Europe B.V.2023-07-03
LED Facial Mask (K213056)Shenzhen Osto Technology Company Limited2022-07-07
The Luminance RED Acne Device (K220729)Luminance Medical Ventures, Inc.2022-06-09
Micro-current facial cold and hot service (model: TPML-100) (K213039)Li-Tek Electronics Technology C0., Ltd.2022-05-25
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.2022-05-20
Shani Darden LED light therapy mask (K214103)Harpar Grace International2022-03-22
reVive Light Therapy Essentials (K210968)Led Technologies, Inc.2021-12-21
MZ Skin LightMAX Supercharged LED Mask 2.0 (K213184)Mz Skin2021-11-23
DemarkQ WOW, DemarkQ POP (K203214)Shenzhen Kaiyan Medical CO , Ltd.2021-07-22
Aduro light therapy Handheld (K203271)Shenzhen Kaiyan Medical CO , Ltd.2021-07-21
Omnilux CLEAR (K210948)Globalmed Technologies2021-06-24
Looper (Model: ZX-579S) (K202055)Heat IN A Click, LLC2021-04-16
PDT-FACE (K192295)Beijing Adss Development Co., Ltd.2020-05-01
Poly Clear (K183708)Medtek Skincare, LLC2019-09-17
dpl SpotLite (K183118)Led Technologies, Inc.2019-02-07
LYFT (K180888)Uplevity, Inc.2018-08-30
LED Light Therapy Device (K180900)Uvbiotek, LLC2018-07-10
Neutrogena Light Therapy Acne Mask+ (K180847)Johnson & Johnson Consumer, Inc.2018-06-19
reVive Light Therapy LED Cleansing System (K180447)Led Technologies, Inc.2018-06-04
SAPPHIRE, ELEVARE SAPPHIRE (K172555)Omm Imports, Inc. D/B/A Zero Gravity2018-05-01
Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) (K161434)Li-Tek Electronics Technologies2017-09-28
Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 (K170111)Pulsaderm, LLC2017-05-08
BC-001+ Acne Purifier (K170260)Oriental Inspiration Limited2017-04-25
LED Phototherapy Device (K162098)Li-Tek Electronic Technology Corporation2017-01-30
Pulsaderm ACE-All Blue (K162371)Nutra Luxe MD, LLC2016-12-15
ESPADA Acne-Clearing Blue Light Pen (K162450)Foreo, Inc.2016-11-30
Pulsaderm Acne Device (K161941)Nutra Luxe MD, LLC2016-10-19
Acne Light Therapy Wand (K160691)Zuko, Inc.2016-06-21
Tria Sapphire (K160821)Tria Beauty, Inc.2016-06-15
Clear Bi-Light (K153081)Michael Todd, LP2016-02-15
SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS (K152889)Biorenew Labs, LLC2015-12-30
Nutra Light Advanced (K150370)Nutra Luxe MD, LLC2015-07-22
LightStim for Acne/ LightStim for Acne Mini (K142246)Led Intellectual Properties, LLC2015-01-29
ULTRA RENEW PLUS (K132833)Accord Media2014-06-17
NUTRA LIGHT BLUE (K132838)Nutra Luxe MD, LLC2014-05-23
LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI (K131461)Led Intellectual Properties, LLC2014-01-06
ILLUMASK ACNE LIGHT THERAPY MASK (K123999)La Lumiere, LLC2013-08-28
TANDA MINI SKINCARE SYSTEM (K124042)Syneron Beauty2013-04-02
SILKN BLUE (K121435)Home Skinovations , Ltd.2013-02-22
CLEARFLASH AC2100 COSMETIC SYSTEM (K111937)Clearflash Technologies, Inc.2012-02-08
QUASAR CALYPSO (K111286)Silver Bay, LLC2012-01-18
NO!NO! SKIN (K102477)Radiancy (Israel) , Ltd.2010-10-04
QUASAR BLUE LIGHT THERAPY SYSTEM (K093963)Silver Bay, LLC2010-08-27
CLARO (K090744)Clrs Technology Corporation2010-04-15
OMNILUX CLEAR-U (K081307)Photo Therapeutics, Inc.2009-01-16

Track OLP automatically

Every clearance here is in the API, with alerts when new ones post.