The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Lpm-1 (laser Power Meter).
| Device ID | K871619 |
| 510k Number | K871619 |
| Device Name: | LPM-1 (LASER POWER METER) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski, VT 05404 |
| Contact | Dave Klyszeiko |
| Correspondent | Dave Klyszeiko BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski, VT 05404 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-27 |
| Decision Date | 1987-07-28 |