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Chromophare F 628 And F 528

by Berchtold GmbH & Co. KG

510(k) K120392

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 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 NumberK120392 Date16 Feb 2012ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1688-2026 FDA Class II initiated 23 Feb 2026

    Surgical light assembly may not adequate support the weight of the ceiling cover.

    • Ongoing Z-1506-2024 FDA Class II initiated 8 Feb 2024

    Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.

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  • Withdrawn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
FSY
Device Class
Class II
Regulation
21 CFR Part 878.4580
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Chromophare F 628 And F 528 is a surgical light, specifically a ceiling mounted light, used to illuminate the operating site on a patient's body with high intensity, shadow-free, cold light. It is designed to reduce color-cast shadows to a minimum in the surgical field.

The device is supplied by Berchtold GmbH & Co. KG and has been authorized with an FDA 510K clearance. It is classified as a class 2 device with a regulation number of 878.4580. The device is intended for use in general and plastic surgery settings, and its specifications include various registration numbers and a product code of FSY.

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