Data / Medical devices / United States / STAAR Surgical Company
STAAR Surgical Company: FDA-registered device maker in Tustin, CA, United States, 8 510(k) clearances and 3 PMA approvals
STAAR Surgical Company is registered with the FDA (registration 3014173684) in Tustin, CA, United States. It lists 6 device types. The FDA files 8 510(k) clearances and 3 PMA approvals under its listings, the newest dated September 6, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014173684
- Address
- 15102 Red Hill Avenue, Tustin, CA, United States, 92780
- Owner or operator
- STAAR SURGICAL Company (2023826)
- Roles
- Specification developer
- First device listed
- October 22, 1992
- Registered through
- 2026
- Brand names listed
- Collamer UVA PC Introcular Lens, EVO VISIAN Implantable Collamer Lens, EVO VISIAN Toric Implantable Collamer Lens, EVO+ VISIAN Implantable Collamer Lens, EVO+ VISIAN Toric Implantable Collamer Lens, Elastic UVA PC Intraocular Lens, Elastimide UVA PC Intraocular Lens, Elastimide UVA PC Toric IOL and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Folders And Injectors, Intraocular Lens (Iol) | MSS | 1 | Specification developer | accessdata.fda.gov |
| Intraocular Lens | HQL | 3 | Specification developer | accessdata.fda.gov |
| Lens, Guide, Intraocular | KYB | 1 | Specification developer | accessdata.fda.gov |
| Lens, Intraocular, Phakic | MTA | 3 | Specification developer | accessdata.fda.gov |
| Lens, Intraocular, Toric Optics | MJP | 3 | Specification developer | accessdata.fda.gov |
| Phakic Toric Intraocular Lens | QCB | 3 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| September 6, 2017 | K172375 | MicroSTAAR Injector System Cartridges | MSS | Substantially Equivalent | STAAR Surgical Company | accessdata.fda.gov |
| October 30, 2015 | K152357 | MicroSTAAR Injector System Cartridges | KYB | Substantially Equivalent | STAAR Surgical Company | accessdata.fda.gov |
| December 22, 2010 | K101782 | MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE | MSS | Substantially Equivalent | Staar Japan | accessdata.fda.gov |
| June 9, 2009 | K090161 | EPIPHANY INJECTION SYSTEM | MSS | Substantially Equivalent | Staar Surgical Co. | accessdata.fda.gov |
| March 13, 2008 | K073586 | MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM | MSS | Substantially Equivalent | Staar Surgical Co. | accessdata.fda.gov |
| September 11, 1998 | K980696 | FOAM TIP INJECTOR | MSS | Substantially Equivalent | Staar Surgical Co. | accessdata.fda.gov |
| December 21, 1995 | K954600 | MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) | KYB | Substantially Equivalent | Staar Surgical Co. | accessdata.fda.gov |
| September 19, 1994 | K940593 | DISPOSABLE MICROSTAAR INJECTOR | KYB | Substantially Equivalent | Staar Sugical | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 22, 2005 | P030016 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | MTA | 45 | March 4, 2026 | accessdata.fda.gov |
| April 2, 2000 | P990013 | COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS | HQL | 38 | July 19, 2021 | accessdata.fda.gov |
| September 16, 1991 | P880091 | ELASTIC UVA PC IOL. | HQL | 29 | September 16, 2010 | accessdata.fda.gov |
Compare with other makers
- All makers of Folders And Injectors, Intraocular Lens (Iol)
- All makers of Lens, Guide, Intraocular
- All makers of Intraocular Lens
- All makers of Lens, Intraocular, Toric Optics
- All makers of Phakic Toric Intraocular Lens
- All makers of Lens, Intraocular, Phakic
Updated March 4, 2026. 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.