The following data is part of a premarket notification filed by Litecure, Llc with the FDA for Litecure Therapy System Model Lts-1500.
| Device ID | K123014 |
| 510k Number | K123014 |
| Device Name: | LITECURE THERAPY SYSTEM MODEL LTS-1500 |
| Classification | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Applicant | LITECURE, LLC 250 Corporate Blvd. Suite B Newark, DE 19702 |
| Contact | Liang Lu |
| Correspondent | Liang Lu LITECURE, LLC 250 Corporate Blvd. Suite B Newark, DE 19702 |
| Product Code | PDZ |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-27 |
| Decision Date | 2013-03-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854103007059 | K123014 | 000 |
| 00854103007035 | K123014 | 000 |