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 |