KTP/532 Surgical Laser
by Laserscope
510(k) K901943
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK901943 | Date29 May 1990 | 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- Withdrawn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
- Full name
- Ktp/532 (Tm) Surgical Laser
- 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, 22 Sep 2026
The KTP/532 Surgical Laser is a medical device classified under product code GEX for General and Plastic Surgery. It is a laser system that uses 532nm wavelength technology for precision soft tissue procedures, including controlled photocoagulation and tissue interaction.
This device is supplied as a surgical laser system intended for use in clinical settings such as urology, ENT, and general or plastic surgery. It is a reusable system requiring appropriate cleaning and maintenance between uses, and its regulatory status is based on FDA 510(k) clearance K901943, granted via the Traditional pathway on May 29, 1990.
Other devices from Laserscope
Questions
AI-generated answers, 22 Sep 2026
What is the KTP/532 Surgical Laser used for?
The KTP/532 Surgical Laser is used for precision soft tissue procedures, including controlled photocoagulation and tissue interaction, in clinical settings such as urology, ENT, and general or plastic surgery.
Is the KTP/532 Surgical Laser reusable or single-use?
The KTP/532 Surgical Laser is a reusable system that requires appropriate cleaning and maintenance between uses to ensure safe and effective operation in clinical environments.
What wavelength does the KTP/532 Surgical Laser operate at?
The KTP/532 Surgical Laser operates at a 532nm wavelength, which enables precise interaction with soft tissue for procedures requiring controlled photocoagulation.
How was the KTP/532 Surgical Laser cleared for market?
The KTP/532 Surgical Laser received FDA 510(k) clearance K901943 via the Traditional pathway on May 29, 1990, based on a determination of substantial equivalence to a predicate device.