LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM— 510(k) K854027

Name: FDA 510(k) clearance K854027
Creator: U.S. Food and Drug Administration
Published: 1985-12-02

Substantially Equivalent

Laserscope

FDA 510(k) clearance K854027 for LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM, Substantially Equivalent on 1985-12-02. Applicant: Laserscope. Device class: 2.

Clearance details

Applicant: Laserscope
Product code: Code LNK
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 1985-10-01
Decision date: 1985-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LNK

view all

K925395 — TECHNOMED PULSOLITH 4000 LASER SYSTEM1993-05-21
K901723 — MDL-2000 LASERTRIPTER1990-07-13
K874253 — ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.1988-07-12
K874255 — ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.1988-07-12
K880193 — MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE1988-04-14

More clearances from Laserscope

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.