Model 451 CO2 Surgical Laser
by Coherent Medical Group 510(k)
Active
510(k) K852190
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK852190 | Date23 Aug 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Model 451 CO2 Surgical Laser is a surgical laser system designed for medical applications. It utilizes carbon dioxide laser technology to perform surgical procedures.
This device is manufactured by Coherent Medical Group and has received FDA 510(k) clearance under the identifier K852190. It is categorized under product code GEX for use in general and plastic surgery settings.
Other devices from Coherent Medical Group
Questions
AI-generated answers, 26 Sep 2026
What is the primary function of the Model 451 CO2 Surgical Laser?
The Model 451 is a surgical laser system that utilizes carbon dioxide laser technology to perform various medical procedures. It is specifically intended for use within general and plastic surgery environments.
What is the regulatory status of this device?
The Model 451 CO2 Surgical Laser has received FDA 510(k) clearance under the identifier K852190. This indicates that the device has been found substantially equivalent to other legally marketed devices for its intended use.
Which medical specialties is this laser system designed for?
This device is categorized under product code GEX, which designates its use for clinical applications within the fields of general and plastic surgery.