Valleylab Ligasure Precise Instrument Vessel Sealing System-Model # LS1200 & Sligaure Generator
510(k) K010010
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK010010 | Date2 Apr 2001 | 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- Withdrawn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
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The LigaSure Precise Instrument Vessel Sealing System is a Vessel Sealing Device (FDA Product Code: GEI) designed to occlude and seal blood vessels and tissue during surgical procedures. It employs advanced radiofrequency energy to create precise, controlled thermal effects, reducing the need for traditional sutures or clips while minimizing collateral tissue damage.
This system consists of a Model # LS1200 instrument paired with a LigaSure Generator, intended for use in general and plastic surgery settings. The device is non-sterile and requires single-use applicators, with the generator serving as a reusable console. It is MRI-unsafe and must be stored in a controlled environment per manufacturer guidelines. The system holds FDA 510(k) clearance (K010010) under the Traditional review pathway, classified as Substantially Equivalent.