The following data is part of a premarket notification filed by Laser Industries Ltd. with the FDA for Sharplan 723 Co2 Laser Surgical System.
Device ID | K801624 |
510k Number | K801624 |
Device Name: | SHARPLAN 723 CO2 LASER SURGICAL SYSTEM |
Classification | Powered Laser Surgical Instrument |
Applicant | LASER INDUSTRIES LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-07-15 |
Decision Date | 1980-08-20 |