The following data is part of a premarket notification filed by Clinicon Corp. with the FDA for Surecaut Diamond Laser Knife.
| Device ID | K983463 |
| 510k Number | K983463 |
| Device Name: | SURECAUT DIAMOND LASER KNIFE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CLINICON CORP. 2752 LOKER AVENUE WEST Carlsbad, CA 92008 |
| Contact | Gerald S Palecki |
| Correspondent | Gerald S Palecki CLINICON CORP. 2752 LOKER AVENUE WEST Carlsbad, CA 92008 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-01 |
| Decision Date | 1998-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850013050147 | K983463 | 000 |
| 00850013050130 | K983463 | 000 |