The following data is part of a premarket notification filed by Laser Spectrum, Inc. with the FDA for Co2 Laser Micromanipulator.
| Device ID | K863520 |
| 510k Number | K863520 |
| Device Name: | CO2 LASER MICROMANIPULATOR |
| Classification | Laser, Surgical, Gynecologic |
| Applicant | LASER SPECTRUM, INC. 5005 NEWPORT DR SUITE 404 Rolling Meadows, IL 60008 |
| Contact | John Gagliardo |
| Correspondent | John Gagliardo LASER SPECTRUM, INC. 5005 NEWPORT DR SUITE 404 Rolling Meadows, IL 60008 |
| Product Code | HHR |
| CFR Regulation Number | 884.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-10 |
| Decision Date | 1986-10-06 |