Chromophare
Surgical Light System ? Ceiling Mounted
18manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (6), Guangdong (5), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Hongbo Optical Instrument Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 1 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Danyang NEW Hope Medical Equipment Co., Ltd. | Danyang | Jiangsu | Manufacturer | 38 |
| Hebei Ruinuo Medical Instrument Co Ltd | Shijiazhuang | Hebei | Manufacturer | 29 |
| Jiangsu Keling Medical Appliances Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 23 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Jiangsu Liangxu Intelligence Science AND Technology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 12 |
| Zhongshan Meiyigou Electronics Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 11 |
| Alltion (Guangxi) Instrument Co., Ltd. | Wuzhou | Guangxi | Manufacturer | 8 |
| Nanchang Micare Medical Equipment Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 8 |
| Shanghai PAX Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
Showing 12 of 18. All 18 manufacturers in China registered for Device, Medical Examination, Ac Powered
Record
| Listed by | Berchtold Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | KZF |
| Device type | Device, Medical Examination, Ac Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6320 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2025-04-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Handling environment humidity 15 to 95 % RH; Handling environment atmospheric pressure 50 to 106 KiloPascal; Storage environment atmospheric pressure 59.5 to 106 KiloPascal; Storage environment temperature -18 to 60 °C; Handling environment temperature -18 to 60 °C; Storage environment humidity 15 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CH00000001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Celestial Star | Sunnex, Inc. | 27 |
| ACEMST1 | Acem SPA | 22 |
| HexaLux | Steris Corporation | 18 |
| Vista LED | Avante | 16 |
| MI Product Line | Medical Illumination International, Inc | 16 |
| Tri Star | Sunnex, Inc. | 14 |
| Verilux | Bear Down Consulting | 14 |
| Midmark | Midmark Corporation | 14 |
| Ritter | Midmark Corporation | 13 |
| PF | Sunnex, Inc. | 13 |
| Kenex | Kenex (Electro-Medical) Ltd. | 13 |
| Lucea LED® | Maquet Gmbh | 12 |
Showing 12 of 63. All products under Device, Medical Examination, Ac Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K935832 | 1994-02-03 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Stryker Communications, Inc. | UDI-DI | 2026-02-23 | Class II | Unknown/Undetermined by firm | Surgical light assembly may not adequate support the weight of the ceiling cover. | 6170 units |
| Stryker Communications, Inc. | UDI-DI | 2025-07-15 | Class II | Component change control | Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur. | 40 |
| Stryker Communications, Inc. | UDI-DI | 2024-02-08 | Class II | Employee error | Due to insufficient mounting force the stability of surgical light system cannot be guaranteed. | 1 unit |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.