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Picolas Neodymium:YAG Ophthalmic Laser

by Synemed, Inc.

PMA P830080

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P830080↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP830080 Date17 Feb 1987ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Picolas Neodymiun-Yag Ophthalmic Laseer
Generic Name
Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
PMA Number
FDA Product Code
LOI
Device Class
Class III
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Picolas Neodymium:YAG Ophthalmic Laser is a neodymium-doped yttrium aluminium garnet (Nd:YAG) laser designed for ophthalmic applications excluding posterior capsulotomy and pupillary cutting. It delivers high-energy laser pulses for precise tissue interaction in eye surgery, adhering to the classification of a Class III device under FDA regulations.

This laser is supplied as a reusable medical device, intended for use in controlled clinical settings such as ophthalmology clinics or surgical suites. It requires proper handling, calibration, and maintenance to ensure safety and efficacy, with no indication of MRI compatibility or specific sterility requirements noted in the data. Authorized under FDA PMA (P830080), it is governed by regulatory standards for ophthalmic lasers, ensuring compliance with device classification and procedural guidelines.

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