The following data is part of a premarket notification filed by La Lumiere, Llc with the FDA for Pro X Otc 5.
| Device ID | K140471 |
| 510k Number | K140471 |
| Device Name: | PRO X OTC 5 |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | LA LUMIERE, LLC 12101 CULLNE BLVD. SUITE A Houston, TX 77047 |
| Contact | M. Joyce Heinrich |
| Correspondent | M. Joyce Heinrich LA LUMIERE, LLC 12101 CULLNE BLVD. SUITE A Houston, TX 77047 |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-25 |
| Decision Date | 2015-01-15 |
| Summary: | summary |