Data / Medical devices / Australia / Norseld Pty. Ltd.
Norseld Pty. Ltd.: FDA-registered device maker in ADELAIDE South Australia, Australia, 1 510(k) clearance
Norseld Pty. Ltd. is registered with the FDA (registration 3008965332) in ADELAIDE South Australia, Australia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 27, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008965332
- Address
- 18 Lowe ST, ADELAIDE South Australia, Australia, 5000
- Owner or operator
- NORSELD PTY. LTD. (9029470)
- Roles
- Manufacturer
- First device listed
- December 7, 2007
- Registered through
- 2026
- Brand names listed
- Copper Bromide Laser, D10B, Dual Yellow, YLite
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 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 |
|---|---|---|---|---|---|---|
| May 27, 2004 | K032397 | DUAL YELLOW LASER, MODEL DUAL YELLOW D10B | GEX | Substantially Equivalent | Norseld Pty., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 27, 2004. 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.