Data / Medical devices / United States / Sunlight Medical, Inc.
Sunlight Medical, Inc.: FDA-registered device maker in Jacksonville, FL, United States, 2 510(k) clearances
Sunlight Medical, Inc. is registered with the FDA (registration 3007086345) in Jacksonville, FL, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated April 30, 2010. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007086345
- Address
- 5570 Florida Mining Blvd S Ste 603, Jacksonville, FL, United States, 32257
- Owner or operator
- Sunlight Medical, Inc. (10025905)
- Roles
- Manufacturer
- First device listed
- May 20, 2008
- Registered through
- 2027
- Brand names listed
- Blastomere biopsy pipette, Denuding Pipettes, Holding Pipettes, ICSI Injection Pipettes, PZD Pipettes, Polar body biopsy pipette, Spermatid Injection Pipettes, Zona Drilling Pipettes
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Microtools, Assisted Reproduction (Pipettes) | MQH | 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 |
|---|---|---|---|---|---|---|
| April 30, 2010 | K092554 | BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES | MQH | Substantially Equivalent | Sunlight Medical, Inc. | accessdata.fda.gov |
| May 19, 2008 | K072600 | INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES | MQH | Substantially Equivalent | Sunlight Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 30, 2010. 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.