The following data is part of a premarket notification filed by Star Medical Technologies, Inc. with the FDA for Lightsheer Pulsed Diode Array Laser System.
| Device ID | K982940 |
| 510k Number | K982940 |
| Device Name: | LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | STAR MEDICAL TECHNOLOGIES, INC. 9516 CANDOR OAKS DR. Raleigh, NC 27615 |
| Contact | Marcy Moore |
| Correspondent | Marcy Moore STAR MEDICAL TECHNOLOGIES, INC. 9516 CANDOR OAKS DR. Raleigh, NC 27615 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-21 |
| Decision Date | 1999-04-08 |
| Summary: | summary |