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 |