The following data is part of a premarket notification filed by Light Age, Inc. with the FDA for Light Age Epicare Alexandrite Laser, Models 501-1h, 501-sp, 501-lp And 501-lpx.
| Device ID | K032991 |
| 510k Number | K032991 |
| Device Name: | LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LIGHT AGE, INC. 500 APGAR DRIVE Somerset, NJ 08873 -1150 |
| Contact | Thomas C Hauck |
| Correspondent | Thomas C Hauck LIGHT AGE, INC. 500 APGAR DRIVE Somerset, NJ 08873 -1150 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-25 |
| Decision Date | 2004-09-14 |
| Summary: | summary |