Derma K Laser System
by Esc Medical Systems, Ltd. 510(k)
Active
510(k) K972872
Overview
The Derma K Laser System is a powered laser surgical instrument designed for use in general and plastic surgery procedures. It utilizes laser technology for surgical applications, though the specific wavelengths or functions are not detailed in the provided information.
The device is manufactured by Esc Medical Systems, Ltd. and is supplied as a reusable system. It received FDA 510(k) clearance on October 28, 1997, with the product code GEX and is classified under 21 CFR 878.4810. The system is intended for use in a clinical setting and requires appropriate storage and handling as a medical device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK972872 | Date28 Oct 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- FDA applicant
- Esc Medical Systems , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Esc Medical Systems, Inc.
Questions
What is the Derma K Laser System used for?
The Derma K Laser System is a powered laser surgical instrument designed specifically for use in general and plastic surgery procedures. It utilizes laser technology for various surgical applications, though the specific wavelengths or functions are not detailed in the provided information.
Is the Derma K Laser System a single-use or reusable device?
The Derma K Laser System is supplied as a reusable system. As a medical device, it requires appropriate storage and handling between uses to maintain its functionality and safety for multiple surgical procedures in a clinical setting.
What is the regulatory status of the Derma K Laser System?
The Derma K Laser System received FDA 510(k) clearance on October 28, 1997, with the product code GEX and is classified under 21 CFR 878.4810. This indicates it was determined to be substantially equivalent to existing devices for its intended use in general and plastic surgery.
Who manufactures the Derma K Laser System and where is it produced?
The Derma K Laser System is manufactured by Esc Medical Systems, Ltd. The company is located in Yokneam, Israel, at Yokneam Industrial Park, P.O. Box 240, with the contact person being ZVI LADIN.