The following data is part of a premarket notification filed by Lutronic Corporation with the FDA for Spectra Laser System.
| Device ID | K103455 |
| 510k Number | K103455 |
| Device Name: | SPECTRA LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUTRONIC CORPORATION 51 EVERETT DRIVE, UNIT A-50 Princeton Junction, NJ 08550 |
| Contact | Jhung Won Vojir |
| Correspondent | Jhung Won Vojir LUTRONIC CORPORATION 51 EVERETT DRIVE, UNIT A-50 Princeton Junction, NJ 08550 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-23 |
| Decision Date | 2011-04-28 |
| Summary: | summary |