The following data is part of a premarket notification filed by Litecure, Llc with the FDA for Lightforce Lts Model 1000, 1500, 2500, And 4000.
| Device ID | K173067 |
| 510k Number | K173067 |
| Device Name: | LightForce LTS Model 1000, 1500, 2500, And 4000 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LiteCure, LLC 250 Corporate Blvd. Suite B Newark, DE 19702 |
| Contact | Eric Rock |
| Correspondent | Curtis M. Egan Certified Compliance Solutions, Inc. 11665 Avena Place Suite 203 San Diego, CA 92128 |
| Product Code | GEX |
| Subsequent Product Code | ILY |
| Subsequent Product Code | PDZ |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854103007073 | K173067 | 000 |
| 00854103007103 | K173067 | 000 |