The following data is part of a premarket notification filed by Light Age, Inc. with the FDA for Epicare-duo Laser System.
Device ID | K091625 |
510k Number | K091625 |
Device Name: | EPICARE-DUO LASER SYSTEM |
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 | 2009-06-03 |
Decision Date | 2009-11-03 |
Summary: | summary |