FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K212275 |
Aesthetic Technology Ltd. |
Dermalux Flex MD |
11/18/2021 |
K223919 |
Bemer INT. AG |
B.Light Clear Evo and B.Light Restore Evo |
09/23/2023 |
K171323 |
Biophotas Inc |
BIOPHOTAS CELLUMA3 |
09/01/2017 |
K132613 |
BIORENEW LABS, LLC |
SONILASE LIGHT THERAPY DEVICE |
02/05/2014 |
K202442 |
Carewear Corp. |
Carewear Firefly Wrinkle Reduction |
11/19/2020 |
K120560 |
Carol Cole Company |
TRINITY WRINKLE REMOVER |
11/06/2012 |
K212947 |
Carol Cole Company dba NuFACE |
Trinity Plus Wrinkle Reducer |
04/02/2022 |
K222377 |
CellReturn Co., LTD. |
Led Mask Platinum Md |
11/03/2022 |
K151337 |
Centre Light Solutions, LLC |
Strialite |
02/24/2016 |
K111454 |
CYNOSURE, INC. |
ILUMINAGE DIODE LASER |
07/05/2012 |
K133473 |
CYNOSURE, INC. |
ILUMINAGE SKIN SMOOTHING LASER |
01/15/2014 |
K222685 |
Dermal Photonics Corp |
NIRA Model 2 |
02/08/2023 |
K163137 |
Dermal Photonics Corporation |
NIRA Beauty Skin Laser |
07/12/2017 |
K214101 |
Duplex International Trading Limited |
Project E Beauty LED Light Therapy Mask (Model: PE730) |
03/23/2022 |
K124064 |
ESPANSIONE MARKETING SPA |
YOUNG AGAIN |
12/19/2013 |
K190443 |
Galactic Beauty, LLC |
MMSphere |
06/24/2019 |
K201107 |
GTG Wellness Co., Ltd. |
Opera Lebody (Gold), Opera Lebody (Zafiro) |
06/22/2020 |
K223544 |
Guangdong Newdermo Biotech Co.,Ltd |
LED light therapy mask (FM-01, FM-02, FM-03) |
02/23/2023 |
K110301 |
HOME SKINOVATIONS LTD. |
SILK'N FX |
08/19/2011 |
K162784 |
Home Skinovations Ltd. |
Silk'n HST |
03/25/2017 |
K221151 |
Hunan Guangye Biotechnology Co., Ltd. |
Beauty LED Mask, Model: KFB265 |
07/19/2022 |
K231555 |
iSMART Developments Ltd |
LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) |
07/27/2023 |
K191629 |
iSMART Marketing Svcs Ltd |
faceLITE |
09/12/2019 |
K180856 |
Johnson & Johnson Consumer, Inc. |
Neutrogena Light Therapy Aging Mask+ |
06/19/2018 |
K140471 |
LA LUMIERE, LLC |
PRO X OTC 5 |
01/15/2015 |
K212771 |
LED Intellectual Properties LLC |
LightStim Elipsa |
01/26/2022 |
K120775 |
LED INTELLECTUAL PROPERTIES, LLC |
LIGHT FOR WRINKLES |
06/04/2012 |
K101190 |
LED INTELLECTUAL PROPERTIES, LLC |
LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC |
07/01/2010 |
K150098 |
LED INTELLECTUAL PROPERTIES, LLC |
LightStim Professional 2-Panel Light |
04/09/2015 |
K151336 |
LED INTELLECTUAL PROPERTIES, LLC |
LightStim Professional 2-Panel Light |
10/23/2015 |
K183247 |
LED Technologies, Inc. |
dpl Faceware |
03/14/2019 |
K171390 |
LED Technologies, Inc. |
dpl II Panel |
08/03/2017 |
K180320 |
LED Technologies, Inc. |
dpl IIa Panel |
04/03/2018 |
K171386 |
LED Technologies, Inc. |
dpl SpectraLite |
08/07/2017 |
K210965 |
LED Technologies, Inc. |
reVive Light Therapy Essentials |
12/15/2021 |
K221430 |
LED Technologies, Inc. |
reVive Light Therapy LED Cleansing System |
07/27/2022 |
K180445 |
LED Technologies, Inc. |
reVive Light Therapy LED Ultrasonic Wrinkle System |
05/15/2018 |
K223482 |
LED Technologies, Inc. |
reVive Light Therapy« Wrinkle and Acne LED Device |
12/21/2022 |
K172662 |
LED Technologies, Inc. |
reVive Perioral |
01/09/2018 |
K101382 |
LED TECHNOLOGIES, LLC |
DPL NUVE |
11/09/2010 |
K141181 |
LED TECHNOLOGIES, LLC |
NUVE FOR WRINKLES, DPL NUVE FOR WRINKLES |
03/31/2015 |
K170984 |
LG Electronics |
LG BEAUTY LED MASK |
08/23/2017 |
K183671 |
LG Electronics, Inc. |
LG PRA.L DERMA LED MASK |
01/22/2019 |
K062991 |
LIGHT BIOSCIENCE, LLC |
GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE |
02/15/2008 |
K223893 |
Light Tree Ventures Europe B.V. |
Infrared Heat (Model: E0221) |
05/16/2023 |
K221444 |
Light Tree Ventures Europe B.V. |
LED Eye Perfector, model: EY-36A, EY-36B |
12/08/2022 |
K221775 |
Light Tree Ventures Europe B.V. |
LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) |
12/20/2022 |
K221946 |
Light Tree Ventures Europe B.V. |
LED Light Therapy Mask (model: MK66R-B) |
11/22/2022 |
K230124 |
Light Tree Ventures Europe B.V. |
LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) |
03/15/2023 |
K230042 |
Light Tree Ventures Europe B.V. |
Q-Rejuvalight Pro Facewear (Model: P19-0023) |
04/28/2023 |
K210823 |
LYMA Life Ltd. |
LYMA Laser |
03/18/2022 |
K180875 |
Medtek Skincare, LLC |
POLY REJUV |
09/14/2018 |
K223147 |
myBlend |
myLEDmask |
05/14/2023 |
K200983 |
Ningbo Hesi Electric Co., Ltd |
Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine |
07/14/2021 |
K141308 |
NUTRA LUXE MD, LLC |
NUTRA LIGHT RED |
08/20/2014 |
K172909 |
Omm Imports d/b/a Zero Gravity |
ELEVARE, PERFECTIO 4 |
06/07/2018 |
K152332 |
OMM IMPORTS INC DBA ZERO GRAVITY |
Perfectio LED infrared device |
02/25/2016 |
K110735 |
PHAROS LIFE CORPORATION |
TANDA MAX OTC SYSTEM |
08/03/2011 |
K072459 |
PHOTO THERAPEUTICS, INC. |
OMNILUX NEW-U |
03/03/2008 |
K181659 |
Premier North America Inc. |
Avologi ENEO |
07/26/2018 |
K213841 |
Premier North America Inc. |
ENEO TOTALE (Model: ENEOT947) |
01/06/2022 |
K092460 |
PS ADVANCED ENGINEERING |
STAR-LITE -LM, MODEL SL8809 |
03/05/2010 |
K133546 |
PS ADVANCED ENGINEERING |
STARLITE-OM, LIGHT EFFECTS, THIBIANT |
08/06/2014 |
K163329 |
PULSADERM LLC |
Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 |
04/14/2017 |
K202390 |
Shenzhen Kaiyan Medical Co Ltd |
Aduro Light Beauty Mask |
07/14/2021 |
K213024 |
Shenzhen Kaiyan Medical Co Ltd |
Oren LED Perioral Light Therapy System |
12/22/2021 |
K220168 |
Shenzhen Kaiyan Medical Co Ltd |
Skin Care Beauty Mask (Model: MJ-06) |
05/17/2022 |
K230351 |
Shenzhen SUNGPO HI-TECH Electronic Co., Ltd |
LED Facial Mask |
05/05/2023 |
K112362 |
SILVER BAY, LLC |
C100 WRINKLE REDUCTION DEVICE |
08/14/2012 |
K130225 |
SILVERBAY LLC, D/B/A QUASAR BIO-TECH |
QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE |
07/11/2013 |
K161849 |
Tanda Beauty Canada Inc. |
Bright |
07/29/2016 |
K230293 |
Therabody, Inc. |
TheraFace Mask |
06/09/2023 |
K212155 |
Theragun, Inc. |
TheraFace LED |
12/21/2021 |
K133896 |
TROPHY SKIN, INC. |
REJUVALITE MD |
11/13/2014 |
K213285 |
Y & J Bio Co., Ltd. |
easy Claire |
03/03/2022 |
K223278 |
Y&J BIO Co., Ltd. |
easy Claire |
11/17/2022 |
K220064 |
YRS Group Inc |
Synergy Marble (Model: Opasm) |
07/22/2022 |
K210954 |
YRS Group Inc. |
Synergy |
06/29/2021 |
K162489 |
Zhongshan Bisen Plastic Electronic Products Co.,Ltd. |
RED Light Device |
01/13/2017 |