The following data is part of a premarket notification filed by La Lumiere, Llc with the FDA for Illumask Acne Light Therapy Mask.
Device ID | K123999 |
510k Number | K123999 |
Device Name: | ILLUMASK ACNE LIGHT THERAPY MASK |
Classification | Over-the-counter Powered Light Based Laser For Acne |
Applicant | LA LUMIERE, LLC 611 W. 5TH ST. Austin, TX 78701 |
Contact | Robert Seiple, Rac |
Correspondent | Robert Seiple, Rac LA LUMIERE, LLC 611 W. 5TH ST. Austin, TX 78701 |
Product Code | OLP |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-26 |
Decision Date | 2013-08-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00070501302743 | K123999 | 000 |
00070501260395 | K123999 | 000 |
00070501260364 | K123999 | 000 |
00070501101261 | K123999 | 000 |
00070501101247 | K123999 | 000 |