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 Nutra Luxe MD, LLC, Led Technologies, Inc. and Led Intellectual Properties, LLC.

51
Total
51
Cleared
181d
Avg days
2009
Since
51 devices
25–48 of 51
Cleared Jun 04, 2018
reVive Light Therapy LED Cleansing System
K180447
Led Technologies, Inc.
General & Plastic Surgery · 104d
Cleared May 01, 2018
SAPPHIRE, ELEVARE SAPPHIRE
K172555
Omm Imports, Inc. D/B/A Zero Gravity
General & Plastic Surgery · 250d
Cleared Sep 28, 2017
Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)
K161434
Li-Tek Electronics Technologies
General & Plastic Surgery · 492d
Cleared May 08, 2017
Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37
K170111
Pulsaderm, LLC
General & Plastic Surgery · 116d
Cleared Apr 25, 2017
BC-001+ Acne Purifier
K170260
Oriental Inspiration Limited
General & Plastic Surgery · 88d
Cleared Jan 30, 2017
LED Phototherapy Device
K162098
Li-Tek Electronic Technology Corporation
General & Plastic Surgery · 185d
Cleared Dec 15, 2016
Pulsaderm ACE-All Blue
K162371
Nutra Luxe MD, LLC
General & Plastic Surgery · 113d
Cleared Nov 30, 2016
ESPADA Acne-Clearing Blue Light Pen
K162450
Foreo, Inc.
General & Plastic Surgery · 90d
Cleared Oct 19, 2016
Pulsaderm Acne Device
K161941
Nutra Luxe MD, LLC
General & Plastic Surgery · 96d
Cleared Jun 21, 2016
Acne Light Therapy Wand
K160691
Zuko, Inc.
General & Plastic Surgery · 102d
Cleared Jun 15, 2016
Tria Sapphire
K160821
Tria Beauty, Inc.
General & Plastic Surgery · 83d
Cleared Feb 15, 2016
Clear Bi-Light
K153081
Michael Todd, LP
General & Plastic Surgery · 115d
Cleared Dec 30, 2015
SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS
K152889
Biorenew Labs, LLC
General & Plastic Surgery · 91d
Cleared Jul 22, 2015
Nutra Light Advanced
K150370
Nutra Luxe MD, LLC
General & Plastic Surgery · 159d
Cleared Jan 29, 2015
LightStim for Acne/ LightStim for Acne Mini
K142246
Led Intellectual Properties, LLC
General & Plastic Surgery · 168d
Cleared Jun 17, 2014
ULTRA RENEW PLUS
K132833
Accord Media
General & Plastic Surgery · 280d
Cleared May 23, 2014
NUTRA LIGHT BLUE
K132838
Nutra Luxe MD, LLC
General & Plastic Surgery · 255d
Cleared Jan 06, 2014
LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI
K131461
Led Intellectual Properties, LLC
General & Plastic Surgery · 231d
Cleared Aug 28, 2013
ILLUMASK ACNE LIGHT THERAPY MASK
K123999
La Lumiere, LLC
General & Plastic Surgery · 245d
Cleared Apr 02, 2013
TANDA MINI SKINCARE SYSTEM
K124042
Syneron Beauty
General & Plastic Surgery · 95d
Cleared Feb 22, 2013
SILKN BLUE
K121435
Home Skinovations , Ltd.
General & Plastic Surgery · 284d
Cleared Feb 08, 2012
CLEARFLASH AC2100 COSMETIC SYSTEM
K111937
Clearflash Technologies, Inc.
General & Plastic Surgery · 215d
Cleared Jan 18, 2012
QUASAR CALYPSO
K111286
Silver Bay, LLC
General & Plastic Surgery · 257d