Data / Medical devices / Singapore / Leica Instruments (singapore) Pte Ltd.
Leica Instruments (singapore) Pte Ltd.: FDA-registered device maker in SINGAPORE South West, Singapore, 1 510(k) clearance
Leica Instruments (singapore) Pte Ltd. is registered with the FDA (registration 1000204638) in SINGAPORE South West, Singapore. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 9, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000204638
- Address
- 15 Tukang Innovation Drive, SINGAPORE South West, Singapore, 618299
- Owner or operator
- Leica Microsystems CMS GmbH (10054809)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- May 8, 2017
- Registered through
- 2026
- Brand names listed
- ARveo 8, ARveo 8x, EnFocus 2300 Integrated OCT System, GLOW800, Leica FL400, Leica FL560, Leica FL560 Procedure Kit, Leica FL800 ULT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Diagnostic Neurosurgical Microscope Filter | QFX | 2 | Contract manufacturer | accessdata.fda.gov |
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | HRM | 1 | Contract manufacturer | accessdata.fda.gov |
| Microscope, Surgical | EPT | 1 | Contract manufacturer | accessdata.fda.gov |
| Microscope, Surgical, General & Plastic Surgery | FSO | 1 | Contract manufacturer | accessdata.fda.gov |
| System, X-Ray, Angiographic | IZI | 2 | Contract manufacturer | accessdata.fda.gov |
| Tomography, Optical Coherence | OBO | 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 |
|---|---|---|---|---|---|---|
| December 9, 2016 | K162783 | EnFocus 2300, EnFocus 4400 | OBO | Substantially Equivalent | Bioptigen, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Microscope, Surgical
- All makers of System, X-Ray, Angiographic
- All makers of Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
- All makers of Diagnostic Neurosurgical Microscope Filter
- All makers of Microscope, Surgical, General & Plastic Surgery
- All makers of Tomography, Optical Coherence
Updated December 9, 2016. 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.