FDA records / Acne light devices
Acne light devices: FDA records
All loaded records in the verified product-code scope. Some refer to professional devices or discontinued models. Inclusion does not establish home use or match a retail product.
51 records
SESE: substantially equivalent 510(k) decision.
| Device name | Applicant | Record | Code | Decision date | Decision |
|---|---|---|---|---|---|
| LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | K253878 | OLP | 2026-03-04 | SESE |
| Erchonia EVRL | Erchonia Corporation | K251843 | OLP | 2025-09-12 | SESE |
| LED Light Therapy Mask (RT01) | Ningbo Dechang Electrical Machinery Made Co.,Ltd | K242068 | OLP | 2025-04-04 | SESE |
| LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) | Shenzhen Eyco Technology Co., Ltd. | K243555 | OLP | 2025-02-05 | SESE |
| BLU TOTALE (Model: ENEOB852) | Premier North America, Inc. | K232656 | OLP | 2023-11-14 | SESE |
| 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 | Dongguan Hunter Electronic Technology Co., Ltd. | K230490 | OLP | 2023-10-27 | SESE |
| LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 | Light Tree Ventures Europe B.V. | K230720 | OLP | 2023-07-03 | SESE |
| LED Facial Mask | Shenzhen Osto Technology Company Limited | K213056 | OLP | 2022-07-07 | SESE |
| The Luminance RED Acne Device | Luminance Medical Ventures, Inc. | K220729 | OLP | 2022-06-09 | SESE |
| Micro-current facial cold and hot service (model: TPML-100) | Li-Tek Electronics Technology C0., Ltd. | K213039 | OLP | 2022-05-25 | SESE |
| Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine | Marci Beauty, Inc. | K210545 | OLP | 2022-05-20 | SESE |
| Shani Darden LED light therapy mask | Harpar Grace International | K214103 | OLP | 2022-03-22 | SESE |
| reVive Light Therapy Essentials | Led Technologies, Inc. | K210968 | OLP | 2021-12-21 | SESE |
| MZ Skin LightMAX Supercharged LED Mask 2.0 | Mz Skin | K213184 | OLP | 2021-11-23 | SESE |
| DemarkQ WOW, DemarkQ POP | Shenzhen Kaiyan Medical CO , Ltd. | K203214 | OLP | 2021-07-22 | SESE |
| Aduro light therapy Handheld | Shenzhen Kaiyan Medical CO , Ltd. | K203271 | OLP | 2021-07-21 | SESE |
| Omnilux CLEAR | Globalmed Technologies | K210948 | OLP | 2021-06-24 | SESE |
| Looper (Model: ZX-579S) | Heat IN A Click, LLC | K202055 | OLP | 2021-04-16 | SESE |
| PDT-FACE | Beijing Adss Development Co., Ltd. | K192295 | OLP | 2020-05-01 | SESE |
| Poly Clear | Medtek Skincare, LLC | K183708 | OLP | 2019-09-17 | SESE |
| dpl SpotLite | Led Technologies, Inc. | K183118 | OLP | 2019-02-07 | SESE |
| LYFT | Uplevity, Inc. | K180888 | OLP | 2018-08-30 | SESE |
| LED Light Therapy Device | Uvbiotek, LLC | K180900 | OLP | 2018-07-10 | SESE |
| Neutrogena Light Therapy Acne Mask+ | Johnson & Johnson Consumer, Inc. | K180847 | OLP | 2018-06-19 | SESE |
| reVive Light Therapy LED Cleansing System | Led Technologies, Inc. | K180447 | OLP | 2018-06-04 | SESE |
| SAPPHIRE, ELEVARE SAPPHIRE | Omm Imports, Inc. D/B/A Zero Gravity | K172555 | OLP | 2018-05-01 | SESE |
| Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) | Li-Tek Electronics Technologies | K161434 | OLP | 2017-09-28 | SESE |
| Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 | Pulsaderm, LLC | K170111 | OLP | 2017-05-08 | SESE |
| BC-001+ Acne Purifier | Oriental Inspiration Limited | K170260 | OLP | 2017-04-25 | SESE |
| LED Phototherapy Device | Li-Tek Electronic Technology Corporation | K162098 | OLP | 2017-01-30 | SESE |
| Pulsaderm ACE-All Blue | Nutra Luxe MD, LLC | K162371 | OLP | 2016-12-15 | SESE |
| ESPADA Acne-Clearing Blue Light Pen | Foreo, Inc. | K162450 | OLP | 2016-11-30 | SESE |
| Pulsaderm Acne Device | Nutra Luxe MD, LLC | K161941 | OLP | 2016-10-19 | SESE |
| Acne Light Therapy Wand | Zuko, Inc. | K160691 | OLP | 2016-06-21 | SESE |
| Tria Sapphire | Tria Beauty, Inc. | K160821 | OLP | 2016-06-15 | SESE |
| Clear Bi-Light | Michael Todd, LP | K153081 | OLP | 2016-02-15 | SESE |
| SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS | Biorenew Labs, LLC | K152889 | OLP | 2015-12-30 | SESE |
| Nutra Light Advanced | Nutra Luxe MD, LLC | K150370 | OLP | 2015-07-22 | SESE |
| LightStim for Acne/ LightStim for Acne Mini | Led Intellectual Properties, LLC | K142246 | OLP | 2015-01-29 | SESE |
| ULTRA RENEW PLUS | Accord Media | K132833 | OLP | 2014-06-17 | SESE |
| NUTRA LIGHT BLUE | Nutra Luxe MD, LLC | K132838 | OLP | 2014-05-23 | SESE |
| LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI | Led Intellectual Properties, LLC | K131461 | OLP | 2014-01-06 | SESE |
| ILLUMASK ACNE LIGHT THERAPY MASK | La Lumiere, LLC | K123999 | OLP | 2013-08-28 | SESE |
| TANDA MINI SKINCARE SYSTEM | Syneron Beauty | K124042 | OLP | 2013-04-02 | SESE |
| SILKN BLUE | Home Skinovations , Ltd. | K121435 | OLP | 2013-02-22 | SESE |
| CLEARFLASH AC2100 COSMETIC SYSTEM | Clearflash Technologies, Inc. | K111937 | OLP | 2012-02-08 | SESE |
| QUASAR CALYPSO | Silver Bay, LLC | K111286 | OLP | 2012-01-18 | SESE |
| NO!NO! SKIN | Radiancy (Israel) , Ltd. | K102477 | OLP | 2010-10-04 | SESE |
| QUASAR BLUE LIGHT THERAPY SYSTEM | Silver Bay, LLC | K093963 | OLP | 2010-08-27 | SESE |
| CLARO | Clrs Technology Corporation | K090744 | OLP | 2010-04-15 | SESE |
| OMNILUX CLEAR-U | Photo Therapeutics, Inc. | K081307 | OLP | 2009-01-16 | SESE |