The following data is part of a premarket notification filed by Lifestream Int'l, Inc. with the FDA for Light-touch And Surgi Light Fibers.
| Device ID | K910726 |
| 510k Number | K910726 |
| Device Name: | LIGHT-TOUCH AND SURGI LIGHT FIBERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LIFESTREAM INT'L, INC. 2828 N.CRESCENT RIVER DR. The Woodlands, TX 77381 |
| Contact | Gerald Abell |
| Correspondent | Gerald Abell 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 | 1991-02-20 |
| Decision Date | 1991-03-29 |