The following data is part of a premarket notification filed by Michael Todd, Lp with the FDA for Clear Bi-light.
| Device ID | K153081 |
| 510k Number | K153081 |
| Device Name: | Clear Bi-Light |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | Michael Todd, LP 648 Port St Lucie Blvd Port St Lucie, FL 34953 |
| Contact | Lilia Friend |
| Correspondent | Sheila Hemeon-heyer Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, MA 01002 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-23 |
| Decision Date | 2016-02-15 |
| Summary: | summary |