The following data is part of a premarket notification filed by Inframed, Inc. with the FDA for Cilas Ym 101 Nd:yag Laser For Neurological Use.
| Device ID | K864610 |
| 510k Number | K864610 |
| Device Name: | CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE |
| Classification | Laser, Neurosurgical, Argon |
| Applicant | INFRAMED, INC. 100 CRESCENT RD. Needham, MA 02194 |
| Contact | Tim Shea |
| Correspondent | Tim Shea INFRAMED, INC. 100 CRESCENT RD. Needham, MA 02194 |
| Product Code | LLF |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-20 |
| Decision Date | 1987-06-18 |