The following data is part of a premarket notification filed by Laserguide with the FDA for Light-touch Fiberoptic Microcontact Probe.
Device ID | K873571 |
510k Number | K873571 |
Device Name: | LIGHT-TOUCH FIBEROPTIC MICROCONTACT PROBE |
Classification | Powered Laser Surgical Instrument |
Applicant | LASERGUIDE 51 SANTA FELICIA DR. Santa Barbara, CA 93117 |
Contact | Robert C Michaels |
Correspondent | Robert C Michaels LASERGUIDE 51 SANTA FELICIA DR. Santa Barbara, CA 93117 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-02 |
Decision Date | 1987-11-06 |