The following data is part of a premarket notification filed by Focus Medical, Llc with the FDA for Naturalase Co2 Laser System.
| Device ID | K152529 |
| 510k Number | K152529 |
| Device Name: | NaturaLase CO2 Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | FOCUS MEDICAL, LLC 23 FRANCIS J CLARKE CIRCLE Bethel, CT 06801 |
| Contact | John B Lee |
| Correspondent | Michail M Pankratov MMP MEDICAL ASSOCIATES LLC 16 APPLETON STREET Waltham, MA 02453 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-03 |
| Decision Date | 2016-02-04 |