The following data is part of a premarket notification filed by Pinpointe Usa, Inc. with the FDA for Pinpointe Footlaser.
| Device ID | K093547 |
| 510k Number | K093547 |
| Device Name: | PINPOINTE FOOTLASER |
| Classification | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Applicant | PINPOINTE USA, INC. 3637 BERNAL AVE. Pleasanton, CA 94566 |
| Contact | Anne Worden |
| Correspondent | Anne Worden PINPOINTE USA, INC. 3637 BERNAL AVE. Pleasanton, CA 94566 |
| Product Code | PDZ |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-17 |
| Decision Date | 2010-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00108690800002 | K093547 | 000 |