The following data is part of a premarket notification filed by Laser Industries Ltd. with the FDA for Laser System, Sharplan 791/he, Co2.
| Device ID | K782030 |
| 510k Number | K782030 |
| Device Name: | LASER SYSTEM, SHARPLAN 791/HE, CO2 |
| 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 | 1978-12-05 |
| Decision Date | 1979-01-22 |