The following data is part of a premarket notification filed by Focus Medical, Llc. with the FDA for Naturalase Piqo4 - Naturalase Nd:y Ag 1064 Q-switched Laser With 532 Nm Accessory And Pulse Slicing Module.
| Device ID | K151473 |
| 510k Number | K151473 |
| Device Name: | NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser With 532 Nm Accessory And Pulse Slicing Module |
| 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 ST Waltham, MA 02453 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-01 |
| Decision Date | 2015-09-01 |
| Summary: | summary |