The following data is part of a premarket notification filed by Lifestream Int'l, Inc. with the FDA for Surgi Light Non-contact Fibers.
| Device ID | K914396 |
| 510k Number | K914396 |
| Device Name: | SURGI LIGHT NON-CONTACT FIBERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LIFESTREAM INT'L, INC. 2828 N.CRESCENT RIVER DR. The Woodlands, TX 77381 |
| Contact | Krista Oakes |
| Correspondent | Krista Oakes LIFESTREAM INT'L, INC. 2828 N.CRESCENT RIVER DR. The Woodlands, TX 77381 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-01 |
| Decision Date | 1991-12-23 |