The following data is part of a premarket notification filed by Novian Health, Inc. with the FDA for Novilase Laser Therapy System, Model Lts-2.
| Device ID | K160392 |
| 510k Number | K160392 |
| Device Name: | Novilase Laser Therapy System, Model LTS-2 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | NOVIAN HEALTH, INC. 430 W. ERIE ST., SUITE 500 Chicago, IL 60654 |
| Contact | William Graveman |
| Correspondent | John Ziobro SPECTRAMEDEX, LLC 117 W. SOUTH STREET Oconomowoc, WI 53066 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-11 |
| Decision Date | 2016-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860008944825 | K160392 | 000 |
| 00860008944887 | K160392 | 000 |
| 00860008944870 | K160392 | 000 |