The following data is part of a premarket notification filed by Light Age, Inc. with the FDA for Light Age Epicare Alexandrite Laser.
| Device ID | K983977 |
| 510k Number | K983977 |
| Device Name: | LIGHT AGE EPICARE ALEXANDRITE LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LIGHT AGE, INC. TWO RIVERVIEW DR. Somerset, NJ 08873 |
| Contact | Susan Laufer |
| Correspondent | Susan Laufer LIGHT AGE, INC. TWO RIVERVIEW DR. Somerset, NJ 08873 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-09 |
| Decision Date | 1999-01-07 |
| Summary: | summary |