CHROMOPHARE— 510(k) K965130

Clearance details

Applicant

Berchtold Holding GmbH

Product code

Code FSY

Device class

Class 2

Regulation

21 CFR 878.4580

Advisory panel

General, Plastic Surgery

Date received

1996-12-23

Decision date

1997-07-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tuttlingen, DE

• K142984 — Leo Minor2014-10-29
• K142076 — CLAVEGUARD FREEDOM SURGICAL LIGHT2014-09-30
• K140812 — MI-750 PROCEDURAL/MINOR SURGICAL LIGHT2014-08-07
• K132551 — ZF 7202014-06-30
• K140930 — VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES2014-06-09

• K083066 — CHROMOPHARE E 778 AND E 5582008-10-30
• K080857 — CHROMOPHARE E-SERIES2008-04-10
• K024132 — CHROMOPHARE X 652003-03-21
• K990656 — CHROMOPHARE D 530 LDR SURGICAL LIGHT1999-07-20
• K991527 — CHROMOPHARE D500, D530, D6501999-05-27

Malfunction

2,759

Other

1

Total

2,760

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →