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Portalase 300 Carbon Dioxide Surgical Laser Gynecologic

by Minnesota Laser Corp.

510(k) K854470

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK854470 Date7 Feb 1986ClearedStatusActive

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  • Withdrawn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 510(k) Active

Specification

510(k)

Full name
Portalase 300 Carbon Dioxide Surg Laser Gynecologi
510(k) Number
FDA Product Code
HHR
Device Class
Class II
Regulation
21 CFR Part 884.4550
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Portalase 300 is a continuous wave carbon dioxide surgical laser designed for use in gynecologic procedures. This device functions by emitting light energy to cut, destroy, or remove tissue during surgery.

This Class II medical device is regulated under FDA 510(k) clearance K854470. It is manufactured by Minnesota Laser Corp. and is classified under regulation number 884.4550.

Other devices from Minnesota Laser Corp.

See all devices from Minnesota Laser Corp. →

Questions

AI-generated answers, 6 Oct 2026

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

  • What is the primary clinical use of the Portalase 300?

    The Portalase 300 is a continuous wave carbon dioxide surgical laser specifically engineered for gynecologic surgical applications. It operates by emitting light energy to perform tissue cutting, destruction, or removal during procedures.

  • What is the regulatory status of the Portalase 300?

    The Portalase 300 is classified as a Class II medical device and is regulated under FDA 510(k) clearance number K854470. It falls under regulation number 884.4550 within the Obstetrics and Gynecology medical specialty.

  • Who manufactures the Portalase 300 and how was it cleared for use?

    The device is manufactured by Minnesota Laser Corp., based in Minneapolis, Minnesota. It was cleared for use following a traditional 510(k) submission process, receiving a decision of substantial equivalence in February 1986.