The following data is part of a premarket notification filed by Pjm Worldwide, Llc D/b/a Phoenix Medical Technology, Llc with the FDA for Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup.
| Device ID | K181253 |
| 510k Number | K181253 |
| Device Name: | Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup |
| Classification | Laser, Comb, Hair |
| Applicant | PJM Worldwide, LLC D/b/a Phoenix Medical Technology, LLC 1499 NW 79th Avenue Miami, FL 33126 |
| Contact | Ira Nusbaum |
| Correspondent | Ronald Berglund Grace Consulting, LLC 6615 Lake Shore Drive, Ste 806 Minneapolis, MN 55423 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-11 |
| Decision Date | 2018-08-10 |
| Summary: | summary |