FDA Product Code
FDA Product Code OLP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4810
510(k) Clearances — 51 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253878 | LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-03-04 | Traditional | PDF ↗ |
| K251843 | Erchonia EVRL | Erchonia Corporation | 2025-09-12 | Traditional | PDF ↗ |
| K242068 | LED Light Therapy Mask (RT01) | Ningbo Dechang Electrical Machinery Made Co.,Ltd | 2025-04-04 | Traditional | PDF ↗ |
| K243555 | LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) | Shenzhen Eyco Technology Co., Ltd. | 2025-02-05 | Traditional | PDF ↗ |
| K232656 | BLU TOTALE (Model: ENEOB852) | Premier North America, Inc. | 2023-11-14 | Traditional | PDF ↗ |
| K230490 | 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. | 2023-10-27 | Traditional | PDF ↗ |
| K230720 | LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 | Light Tree Ventures Europe B.V. | 2023-07-03 | Traditional | PDF ↗ |
| K213056 | LED Facial Mask | Shenzhen Osto Technology Company Limited | 2022-07-07 | Traditional | PDF ↗ |
| K220729 | The Luminance RED Acne Device | Luminance Medical Ventures, Inc. | 2022-06-09 | Traditional | PDF ↗ |
| K213039 | Micro-current facial cold and hot service (model: TPML-100) | Li-Tek Electronics Technology C0., Ltd. | 2022-05-25 | Traditional | PDF ↗ |
| K210545 | 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. | 2022-05-20 | Traditional | PDF ↗ |
| K214103 | Shani Darden LED light therapy mask | Harpar Grace International | 2022-03-22 | Traditional | PDF ↗ |
| K210968 | reVive Light Therapy Essentials | Led Technologies, Inc. | 2021-12-21 | Traditional | PDF ↗ |
| K213184 | MZ Skin LightMAX Supercharged LED Mask 2.0 | Mz Skin | 2021-11-23 | Traditional | PDF ↗ |
| K203214 | DemarkQ WOW, DemarkQ POP | Shenzhen Kaiyan Medical CO , Ltd. | 2021-07-22 | Traditional | PDF ↗ |
| K203271 | Aduro light therapy Handheld | Shenzhen Kaiyan Medical CO , Ltd. | 2021-07-21 | Traditional | PDF ↗ |
| K210948 | Omnilux CLEAR | Globalmed Technologies | 2021-06-24 | Traditional | PDF ↗ |
| K202055 | Looper (Model: ZX-579S) | Heat IN A Click, LLC | 2021-04-16 | Traditional | PDF ↗ |
| K192295 | PDT-FACE | Beijing Adss Development Co., Ltd. | 2020-05-01 | Traditional | PDF ↗ |
| K183708 | Poly Clear | Medtek Skincare, LLC | 2019-09-17 | Traditional | PDF ↗ |
| K183118 | dpl SpotLite | Led Technologies, Inc. | 2019-02-07 | Traditional | PDF ↗ |
| K180888 | LYFT | Uplevity, Inc. | 2018-08-30 | Traditional | PDF ↗ |
| K180900 | LED Light Therapy Device | Uvbiotek, LLC | 2018-07-10 | Traditional | PDF ↗ |
| K180847 | Neutrogena Light Therapy Acne Mask+ | Johnson & Johnson Consumer, Inc. | 2018-06-19 | Traditional | PDF ↗ |
| K180447 | reVive Light Therapy LED Cleansing System | Led Technologies, Inc. | 2018-06-04 | Traditional | PDF ↗ |
| K172555 | SAPPHIRE, ELEVARE SAPPHIRE | Omm Imports, Inc. D/B/A Zero Gravity | 2018-05-01 | Traditional | PDF ↗ |
| K161434 | Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) | Li-Tek Electronics Technologies | 2017-09-28 | Traditional | PDF ↗ |
| K170111 | Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 | Pulsaderm, LLC | 2017-05-08 | Traditional | PDF ↗ |
| K170260 | BC-001+ Acne Purifier | Oriental Inspiration Limited | 2017-04-25 | Traditional | PDF ↗ |
| K162098 | LED Phototherapy Device | Li-Tek Electronic Technology Corporation | 2017-01-30 | Traditional | PDF ↗ |
| K162371 | Pulsaderm ACE-All Blue | Nutra Luxe MD, LLC | 2016-12-15 | Traditional | PDF ↗ |
| K162450 | ESPADA Acne-Clearing Blue Light Pen | Foreo, Inc. | 2016-11-30 | Traditional | PDF ↗ |
| K161941 | Pulsaderm Acne Device | Nutra Luxe MD, LLC | 2016-10-19 | Traditional | PDF ↗ |
| K160691 | Acne Light Therapy Wand | Zuko, Inc. | 2016-06-21 | Traditional | PDF ↗ |
| K160821 | Tria Sapphire | Tria Beauty, Inc. | 2016-06-15 | Traditional | PDF ↗ |
| K153081 | Clear Bi-Light | Michael Todd, LP | 2016-02-15 | Traditional | PDF ↗ |
| K152889 | SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS | Biorenew Labs, LLC | 2015-12-30 | Traditional | PDF ↗ |
| K150370 | Nutra Light Advanced | Nutra Luxe MD, LLC | 2015-07-22 | Traditional | PDF ↗ |
| K142246 | LightStim for Acne/ LightStim for Acne Mini | Led Intellectual Properties, LLC | 2015-01-29 | Traditional | PDF ↗ |
| K132833 | ULTRA RENEW PLUS | Accord Media | 2014-06-17 | Traditional | PDF ↗ |
| K132838 | NUTRA LIGHT BLUE | Nutra Luxe MD, LLC | 2014-05-23 | Traditional | PDF ↗ |
| K131461 | LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI | Led Intellectual Properties, LLC | 2014-01-06 | Traditional | PDF ↗ |
| K123999 | ILLUMASK ACNE LIGHT THERAPY MASK | La Lumiere, LLC | 2013-08-28 | Traditional | PDF ↗ |
| K124042 | TANDA MINI SKINCARE SYSTEM | Syneron Beauty | 2013-04-02 | Special | PDF ↗ |
| K121435 | SILKN BLUE | Home Skinovations , Ltd. | 2013-02-22 | Traditional | PDF ↗ |
| K111937 | CLEARFLASH AC2100 COSMETIC SYSTEM | Clearflash Technologies, Inc. | 2012-02-08 | Traditional | PDF ↗ |
| K111286 | QUASAR CALYPSO | Silver Bay, LLC | 2012-01-18 | Traditional | PDF ↗ |
| K102477 | NO!NO! SKIN | Radiancy (Israel) , Ltd. | 2010-10-04 | Traditional | PDF ↗ |
| K093963 | QUASAR BLUE LIGHT THERAPY SYSTEM | Silver Bay, LLC | 2010-08-27 | Traditional | PDF ↗ |
| K090744 | CLARO | Clrs Technology Corporation | 2010-04-15 | Traditional | PDF ↗ |
| K081307 | OMNILUX CLEAR-U | Photo Therapeutics, Inc. | 2009-01-16 | Traditional | PDF ↗ |
Product code OLP · Class II · General, Plastic Surgery. Data: openFDA.