Sharplan 720 CO2 Surgical Laser
510(k) K820101
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK820101 | Date24 Feb 1982 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEX
- FDA applicant
- Laser Industries , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Sharplan 720 CO2 Surgical Laser is a CO2 laser system designed for surgical applications. It is available in various power configurations including 25 watt, 40 watt, 60 watt, and 80 watt systems, with the 80 watt model intended for high power needs such as neurosurgery. The system can be used with a 120mm handpiece for general surgical applications and with a micromanipulator for GYN and ENT procedures.
The micromanipulator can adapt to Zeiss or Wild/Leica microscopes for precision micro-laryngeal and lower GYN procedures. The device is supplied as part of the SHARPLAN family of CO2 lasers and includes various accessories. It received FDA 510(k) clearance on February 24, 1982, with product code GEX and is manufactured by Laser Industries, Ltd.