The following data is part of a premarket notification filed by Transmedica Intl., Inc. with the FDA for Laser Lancet Lb100.
| Device ID | K980538 |
| 510k Number | K980538 |
| Device Name: | LASER LANCET LB100 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TRANSMEDICA INTL., INC. 323 CENTER ST., SUITE 1100 Little Rock, AR 72201 |
| Contact | Kevin Marchitto |
| Correspondent | Kevin Marchitto TRANSMEDICA INTL., INC. 323 CENTER ST., SUITE 1100 Little Rock, AR 72201 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-11 |
| Decision Date | 1998-07-09 |
| Summary: | summary |