The following data is part of a premarket notification filed by Novalis Medical, Llc with the FDA for Clareon And Solarus Pulsed Light Devices And Accessories.
| Device ID | K043319 |
| 510k Number | K043319 |
| Device Name: | CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES |
| Classification | Powered Laser Surgical Instrument |
| Applicant | NOVALIS MEDICAL, LLC 1719 W. KENNEDY BLVD. Tampa, FL 33606 |
| Contact | Anthony Davis |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-12-02 |
| Decision Date | 2004-12-17 |
| Summary: | summary |