The following data is part of a premarket notification filed by Palomar Medical Technologies, Inc. with the FDA for Qyag Laser System.
| Device ID | K130250 |
| 510k Number | K130250 |
| Device Name: | QYAG LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PALOMAR MEDICAL TECHNOLOGIES, INC. 15 NETWORK DR Burlington, MA 01803 |
| Contact | Nicole Brown |
| Correspondent | Nicole Brown 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 | 2013-02-01 |
| Decision Date | 2013-05-03 |
| Summary: | summary |