The following data is part of a premarket notification filed by Luminance Medical Ventures, Inc. with the FDA for The Luminance Red Acne Device.
| Device ID | K220729 |
| 510k Number | K220729 |
| Device Name: | The Luminance RED Acne Device |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | Luminance Medical Ventures, Inc. 2310 Henderson Avenue #1297 Dallas, TX 75201 |
| Contact | Troy Stites |
| Correspondent | Laura Nygard leanRAQA, LLC 131 E Loch Lomond Dr Oro Valley, AZ 85737 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-14 |
| Decision Date | 2022-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002593036 | K220729 | 000 |