Data / Medical devices / Australia / Dimple Optics Pty Ltd
Dimple Optics Pty Ltd: FDA-registered device maker in Rosebery New South Wales, Australia, 3 510(k) clearances
Dimple Optics Pty Ltd is registered with the FDA (registration 3030262618) in Rosebery New South Wales, Australia. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 15, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030262618
- Address
- 87-103 Epsom Rd Unit 13, Rosebery New South Wales, Australia, 2018
- Owner or operator
- Dimple Optics Pty Ltd (10094490)
- Roles
- Exporter to the US
- First device listed
- December 3, 2025
- Registered through
- 2026
- Brand names listed
- Dimple - Soft Contact Lens
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | 2 | Exporter to the US | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| October 15, 2020 | K200296 | Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses | LPL | Substantially Equivalent | Pegavision Corporation | accessdata.fda.gov |
| August 26, 2016 | K161124 | EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear | LPL | Substantially Equivalent | Vision Science Co., Ltd. | accessdata.fda.gov |
| March 5, 2014 | K132714 | ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR, TINTED, AND COSMETIC TINTED) | LPL | Substantially Equivalent | Vision Science Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 15, 2020. 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.