The following data is part of a premarket notification filed by Palomar Medical Technologies, Inc. with the FDA for Palomar Vectus Laser.
| Device ID | K120622 |
| 510k Number | K120622 |
| Device Name: | PALOMAR VECTUS LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PALOMAR MEDICAL TECHNOLOGIES, INC. 15 NETWORK DR Burlington, MA 01803 |
| Contact | Sharon Timberlake |
| Correspondent | Sharon Timberlake PALOMAR MEDICAL TECHNOLOGIES, INC. 15 NETWORK DR Burlington, MA 01803 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-01 |
| Decision Date | 2012-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494108038 | K120622 | 000 |
| 00841494100636 | K120622 | 000 |
| 00841494100612 | K120622 | 000 |
| 00841494100162 | K120622 | 000 |
| 00841494100155 | K120622 | 000 |
| 00841494100148 | K120622 | 000 |
| 00841494100131 | K120622 | 000 |
| 00841494100124 | K120622 | 000 |
| 00841494103507 | K120622 | 000 |