OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN— 510(k) K863221

Substantially Equivalent

Laserscope

FDA 510(k) clearance K863221 for OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN, Substantially Equivalent on 1987-03-02. Applicant: Laserscope. Device class: 2.

Clearance details

Applicant
Laserscope
Product code
Code HHR
Device class
Class 2
Regulation
21 CFR 884.4550
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Santa Clara, CA, US
Download summary PDFView on FDA.gov ↗

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