The following data is part of a premarket notification filed by Medical Energy, Inc. with the FDA for Lightforce Lf 20/30 980nm Surgical Diode Laser System.
| Device ID | K041419 |
| 510k Number | K041419 |
| Device Name: | LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MEDICAL ENERGY, INC. 225 EAST ZARAGOZA ST. Pensacola, FL 32501 |
| Contact | David P Lewing |
| Correspondent | David P Lewing MEDICAL ENERGY, INC. 225 EAST ZARAGOZA ST. Pensacola, FL 32501 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-28 |
| Decision Date | 2004-08-26 |
| Summary: | summary |