The following data is part of a premarket notification filed by Light Age, Inc. with the FDA for Epicare Yag.
| Device ID | K113115 |
| 510k Number | K113115 |
| Device Name: | EPICARE YAG |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LIGHT AGE, INC. 500 APGAR DRIVE Somerset, NJ 08873 -1150 |
| Contact | Elizabeth Reddington |
| Correspondent | Elizabeth Reddington 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 | 2011-10-21 |
| Decision Date | 2012-04-03 |
| Summary: | summary |