The following data is part of a premarket notification filed by Lifestream Int'l, Inc. with the FDA for Diomed 15, 30, 60 Surgical Diode Laser.
| Device ID | K962354 |
| 510k Number | K962354 |
| Device Name: | DIOMED 15, 30, 60 SURGICAL DIODE LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LIFESTREAM INT'L, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Steven Clarke |
| Correspondent | Steven Clarke LIFESTREAM INT'L, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-18 |
| Decision Date | 1996-09-11 |
| Summary: | summary |