Data / Medical devices / United States / Metro Optics of Austin, Inc.
Metro Optics of Austin, Inc.: FDA-registered device maker in Pflugerville, TX, United States, 24 510(k) clearances and 1 PMA approval
Metro Optics of Austin, Inc. is registered with the FDA (registration 1627258) in Pflugerville, TX, United States. It lists 1 device type. The FDA files 24 510(k) clearances and 1 PMA approval under its listings, the newest dated April 3, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1627258
- Address
- 15802 Vision Drive, Pflugerville, TX, United States, 78660
- Owner or operator
- METRO OPTICS OF AUSTIN, LTD. (1627258)
- Roles
- Manufacturer
- First device listed
- January 18, 2008
- Registered through
- 2027
- Brand names listed
- MetroSoft
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lenses, Soft Contact, Daily Wear | LPL | 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 3, 2024 | K240618 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens | HQD | Substantially Equivalent | Acuity Polymers, Inc. | accessdata.fda.gov |
| February 6, 2024 | K233221 | Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) | LPL | Substantially Equivalent | Metro Optics of Austin, Inc. | accessdata.fda.gov |
| June 16, 2023 | K230965 | Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lens | HQD | Substantially Equivalent | Acuity Polymers, Inc. | accessdata.fda.gov |
| February 12, 2019 | K183167 | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens | HQD | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| June 8, 2018 | K180988 | Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens | HQD | Substantially Equivalent | Acuity Polymers, Inc. | accessdata.fda.gov |
| March 16, 2018 | K180172 | FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG | HQD | Substantially Equivalent | Paragon Vision Sciences | accessdata.fda.gov |
| August 1, 2017 | K171077 | HEXA100 (hexafocon A) Daily Wear Contact Lenses | HQD | Substantially Equivalent | Contamac, Ltd. | accessdata.fda.gov |
| August 10, 2016 | K161100 | Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses | HQD | Substantially Equivalent | Contamac, Ltd. | accessdata.fda.gov |
| January 21, 2011 | K102154 | TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS | HQD | Substantially Equivalent | The Lagado Corp. | accessdata.fda.gov |
| October 28, 2010 | K100244 | METRO SOFT | LPL | Substantially Equivalent | Metro Optics of Austin, Inc. | accessdata.fda.gov |
| July 23, 2008 | K080512 | REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT | LPL | Substantially Equivalent | Metro Optics of Austin, Inc. | accessdata.fda.gov |
| September 16, 2004 | K033599 | ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS | HQD | Substantially Equivalent | The Lagado Corp. | accessdata.fda.gov |
| August 1, 2003 | K031532 | SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT LENS FOR DAILY WEAR | LPL | Substantially Equivalent | Metro Optics of Austin, Inc. | accessdata.fda.gov |
| February 12, 2003 | K024164 | COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT | HQD | Substantially Equivalent | Metro Optics, Inc. | accessdata.fda.gov |
| February 16, 2001 | K003933 | BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY | MUW | Substantially Equivalent | Polymer Technology | accessdata.fda.gov |
| June 13, 2000 | K001620 | METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN | LPL | Substantially Equivalent | Metro Optics of Austin, Inc. | accessdata.fda.gov |
| June 13, 2000 | K001584 | METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT | LPL | Substantially Equivalent | Medvice Consulting, Inc. | accessdata.fda.gov |
| March 31, 1999 | K990264 | COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS | HQD | Substantially Equivalent | Metro Optics of Austin, Inc. | accessdata.fda.gov |
| December 22, 1998 | K983773 | BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS | LPL | Substantially Equivalent | Benz Research and Development Corp. | accessdata.fda.gov |
| March 30, 1998 | K974636 | FLOSI RIGID GAS PERMEABLE CONTACT LENS | HQD | Substantially Equivalent | Futuristic Design Assoc. | accessdata.fda.gov |
| March 11, 1997 | K964902 | CONTACT LENSES METRO-G 3X (HIOXIFILCON B) | LPL | Substantially Equivalent | Metro Optics of Austin, Inc. | accessdata.fda.gov |
| November 20, 1996 | K961606 | METRO FOCAL ASPHERIC (POLYMACON) | LPL | Substantially Equivalent | Metro Optics of Austin, Inc. | accessdata.fda.gov |
| October 9, 1996 | K962006 | MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS | HQD | Substantially Equivalent | Menicon Co, Ltd. | accessdata.fda.gov |
| December 7, 1994 | K944223 | ACCUCON | HQD | Substantially Equivalent | Innovision, Inc. | 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 |
|---|---|---|---|---|---|---|
| October 25, 1985 | P820026 | METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT | LPL | 8 | September 17, 1990 | accessdata.fda.gov |
Compare with other makers
Updated April 3, 2024. 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.