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510(k) K012852

EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS by Optonol, Ltd. — Product Code KYF

K012852 is an FDA 510(k) premarket notification submitted by Optonol, Ltd. for the device "EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS". The FDA issued a decision of Substantially Equivalent on March 26, 2002. The device falls under product code KYF (Implant, Eye Valve), a Class II device regulated under 21 CFR 886.3920. Optonol, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2002
Date Received
August 24, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Eye Valve
Device Class
Class II
Regulation Number
886.3920
Review Panel
OP
Submission Type

Other clearances by Optonol, Ltd.

  • K030350 — EXPRESS MINI GLAUCOMA SHUNT (March 13, 2003)

Other clearances for product code KYF

  • K231051 — Ahmed® Glaucoma Valve Model FP8 (May 12, 2023)
  • K230975 — Ahmed® Glaucoma Valve Model FP7 (May 12, 2023)
  • K220032 — iStent infinite Trabecular Micro-Bypass System, Model iS3 (August 2, 2022)
  • K182518 — AHMED ClearPath Glaucoma Drainage Device (January 18, 2019)
  • K171451 — Ahmed Glaucoma Valve Model FP8 (August 8, 2017)
  • K161457 — XEN Glaucoma Treatment System (November 21, 2016)
  • K162060 — Ahmed Glaucoma Valve (October 24, 2016)
  • K152996 — Molteno3 Glaucoma Implant (December 17, 2015)
  • K062252 — MOLTENO3 (September 27, 2006)
  • K060644 — AHMED GLAUCOMA VALVE, MODEL M4 (September 18, 2006)

FDA data resources