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Buffalo Filter Virosafe Erbium:yag Filter - #VSEYAG1-4 Buffalo Filter Virosafe Erbium:yag Prefilter - #BFEYAG04PF

by Buffalo Filter Co., Inc.

510(k) K983298

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK983298 Date16 Aug 1999ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1795-2022 FDA Class III initiated 25 May 2022

    Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

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  • Withdrawn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
FYD
Device Class
Class II
Regulation
21 CFR Part 878.5070
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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