Data / Medical devices / Japan / DKK Dai-Ichi Shomei Co, Ltd
DKK Dai-Ichi Shomei Co, Ltd: FDA-registered device maker in ITABASHI-KU Tokyo, Japan, 1 510(k) clearance
DKK Dai-Ichi Shomei Co, Ltd is registered with the FDA (registration 3006437518) in ITABASHI-KU Tokyo, Japan. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 6, 2007. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3006437518
- Address
- 1-32-26, Sakashita, ITABASHI-KU Tokyo, Japan, 174-0043
- Owner or operator
- DKK DAI-ICHI SHOMEI CO, LTD (9042505)
- Roles
- Manufacturer
- First device listed
- November 15, 2007
- Registered through
- 2027
- Brand names listed
- Aurora 2 Series, Aurora 3 Series, Aurora 4 Series, Aurora Astro Series, Aurora Series, Aurora series, Aurora 2 series, Aurora 3 series and Aurora 4 series, Camera for Aurora 3 and Aurora Four Lights and Lumos series, Lucina4 Series and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Surgical And Accessories | KQM | 1 | Manufacturer | accessdata.fda.gov |
| Device, Medical Examination, Ac Powered | KZF | 1 | Manufacturer | accessdata.fda.gov |
| Light, Surgical, Accessories | FTA | 2 | Manufacturer | accessdata.fda.gov |
| Light, Surgical, Ceiling Mounted | FSY | 2 | Manufacturer | accessdata.fda.gov |
| Light, Surgical, Floor Standing | FSS | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 6, 2007 | K071698 | AURORA LED SERIES SURGICAL LIGHTS | FSY | Substantially Equivalent | Skytron, Div. the Kmw Group, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 9, 2024 | 94979 | Class II | Ongoing | Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site. | The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching. | accessdata.fda.gov |
| August 23, 2023 | 92999 | Class II | Ongoing | LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Arm System Model Numbers LFS | The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the flat screen attached to the LFS flat screen system can rotate beyond the original angle limit and it could cause excessive force to be given to the spring shaft of the LFS bracket. Due to the excessive force given to the spring shaft, the spring shaft could break | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Medical Examination, Ac Powered
- All makers of Light, Surgical, Ceiling Mounted
- All makers of Light, Surgical, Floor Standing
- All makers of Camera, Surgical And Accessories
- All makers of Light, Surgical, Accessories
Updated August 14, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.