Metro Optics Of Austin, Inc.

FDA Regulatory Profile

Metro Optics Of Austin, Inc. appears in FDA public data with 0 recalls, 8 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent FDA inspection ended on Sep 19, 2018 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on Feb 6, 2024.

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Summary

Total Recalls
0
510(k) Clearances
8
Inspections
2
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 19, 2018Pflugerville, TXDevicesNo Action Indicated (NAI)1627258
Feb 26, 2016Pflugerville, TXDevicesVoluntary Action Indicated (VAI)1627258

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K233221Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)Feb 6, 2024
K100244METRO SOFTOct 28, 2010
K080512REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY…Jul 23, 2008
K031532SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT LENS FOR DAILY WEARAug 1, 2003
K001620METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY…Jun 13, 2000
K990264COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENSMar 31, 1999
K964902CONTACT LENSES METRO-G 3X (HIOXIFILCON B)Mar 11, 1997
K961606METRO FOCAL ASPHERIC (POLYMACON)Nov 20, 1996