The following data is part of a premarket notification filed by Light Age, Inc. with the FDA for Q-clear.
Device ID | K110370 |
510k Number | K110370 |
Device Name: | Q-CLEAR |
Classification | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
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 | PDZ |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-02-08 |
Decision Date | 2011-09-15 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
Q-CLEAR 85751405 4391011 Live/Registered |
Light Age, Inc. 2012-10-11 |