The following data is part of a premarket notification filed by California Laboratories, Inc. with the FDA for Hexascan Handpiece For Argon/dye Laser.
| Device ID | K884431 |
| 510k Number | K884431 |
| Device Name: | HEXASCAN HANDPIECE FOR ARGON/DYE LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CALIFORNIA LABORATORIES, INC. 5964 LA PLACE COURT Carlsbad, CA 92008 -8861 |
| Contact | Kenneth R Michael |
| Correspondent | Kenneth R Michael CALIFORNIA LABORATORIES, INC. 5964 LA PLACE COURT Carlsbad, CA 92008 -8861 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-21 |
| Decision Date | 1988-12-02 |