The following data is part of a premarket notification filed by Focus Medical, Llc. with the FDA for Naturalase Diode Laser Family Naturalase Model Nl980, Naturalase Diode Laser Family Naturalase Nl810.
| Device ID | K101152 |
| 510k Number | K101152 |
| Device Name: | NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | FOCUS MEDICAL, LLC. 23 FRANCIS J. CLARKE CIRCLE Bethel, CT 06801 |
| Contact | John Lee |
| Correspondent | John Lee FOCUS MEDICAL, LLC. 23 FRANCIS J. CLARKE CIRCLE Bethel, CT 06801 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-23 |
| Decision Date | 2010-08-18 |
| Summary: | summary |