The following data is part of a premarket notification filed by Laser Peripherals Llc. with the FDA for Laseguide Cat # Clf-600d & Clf-1000d.
| Device ID | K901786 |
| 510k Number | K901786 |
| Device Name: | LASEGUIDE CAT # CLF-600D & CLF-1000D |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASER PERIPHERALS LLC. 35 POND PARK RD. #9 Hingham, MA 02043 |
| Contact | J Pietrafitta |
| Correspondent | J Pietrafitta LASER PERIPHERALS LLC. 35 POND PARK RD. #9 Hingham, MA 02043 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-18 |
| Decision Date | 1990-06-27 |