The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for Slt Contact Laser System Oculoplastics.
| Device ID | K881134 |
| 510k Number | K881134 |
| Device Name: | SLT CONTACT LASER SYSTEM OCULOPLASTICS |
| Classification | Laser, Ophthalmic |
| Applicant | SURGICAL LASER TECHNOLOGIES, INC. ONE GREAT VALLEY PKWY. Malvern, PA 19355 |
| Contact | Gifford, R.n. |
| Correspondent | Gifford, R.n. SURGICAL LASER TECHNOLOGIES, INC. ONE GREAT VALLEY PKWY. Malvern, PA 19355 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-16 |
| Decision Date | 1988-06-06 |