The following data is part of a premarket notification filed by Pentax Medical Company with the FDA for Isc-1000 Pentax Confocal Laser System.
| Device ID | K042740 |
| 510k Number | K042740 |
| Device Name: | ISC-1000 PENTAX CONFOCAL LASER SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | PENTAX MEDICAL COMPANY 102 CHESTNUT RIDGE ROAD Montvale, NJ 07645 |
| Contact | Paul Silva |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-10-04 |
| Decision Date | 2004-10-19 |
| Summary: | summary |