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Wave Form Manufacturing Prolase General Shaped Fiber

by Wave Form Mfg., Inc.

510(k) K020673

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK020673 Date30 May 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Wave Form Manufacturing Prolase General Shaped Fiber is a laser fiber device intended for use in vaporization, cutting, ablation, and coagulation of soft tissue. It is a general-shaped fiber designed for delivery of laser energy in surgical procedures.

The device is supplied as a single-use fiber and is indicated for use in plastic surgery and general surgical settings. It received FDA 510(k) clearance (K020673) on May 30, 2002, and is manufactured by Wave Form Mfg., Inc. No information regarding sterility, MRI safety, storage conditions, or reusable design is provided in the data.

Questions

AI-generated answers, 28 Sep 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 Wave Form Manufacturing Prolase General Shaped Fiber used for?

    It is intended for use in vaporization, cutting, ablation, and coagulation of soft tissue during surgical procedures, specifically in plastic surgery and general surgical settings, as indicated in the device description.

  • Is the Wave Form Manufacturing Prolase General Shaped Fiber reusable or single-use?

    The device is supplied as a single-use fiber, meaning it is intended for one procedure only and should not be reused, based on the explicit statement in the device data.

  • What regulatory clearance does the Wave Form Manufacturing Prolase General Shaped Fiber have?

    It received FDA 510(k) clearance under K020673 on May 30, 2002, and was determined to be substantially equivalent to a predicate device, as stated in the authorizations and specifications.