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510(k) K003820

DISPOSABLE CB-PE MICROKERATOME BLADES by Oasis Medical, Inc. — Product Code HNO

K003820 is an FDA 510(k) premarket notification submitted by Oasis Medical, Inc. for the device "DISPOSABLE CB-PE MICROKERATOME BLADES". The FDA issued a decision of Substantially Equivalent on March 8, 2001. The device falls under product code HNO (Keratome, Ac-Powered), a Class I device regulated under 21 CFR 886.4370. Oasis Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2001
Date Received
December 11, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratome, Ac-Powered
Device Class
Class I
Regulation Number
886.4370
Review Panel
OP
Submission Type

Other clearances by Oasis Medical, Inc.

  • K213988 — SOFT PLUG Extended Duration 180 Tapered Canalicular Plug (June 3, 2022)
  • K162361 — Soft Plug Extended Duration 180 Canalicular Plug (April 17, 2017)
  • K032297 — DISPOSABLE N-PE MICKROKERATOME BLADES (August 26, 2003)
  • K030401 — DISPOSABLE M2-PE MICROKERATOME BLADES (June 19, 2003)
  • K022205 — DISPOSABLE N-PE MICROKERATOME BLADES (October 3, 2002)
  • K013613 — SOFT PLUG ABSORBABLE PLUG-SA (June 27, 2002)
  • K001176 — DISPOSABLE MICROKERATOME BLADES-PE (September 21, 2000)
  • K980437 — SILICONE PUNCTAL PLUG (April 30, 1998)
  • K950798 — POSTERIOR CAPSULE SHIELD (May 22, 1995)
  • K950241 — OPHTHALMIC SPONGES (February 27, 1995)

Other clearances for product code HNO

  • K173371 — VisuMax Femtosecond Laser (April 13, 2018)
  • K172994 — EPI K Console (October 26, 2017)
  • K072102 — EPIVISION SL SYSTEM (January 16, 2009)
  • K082043 — CARRIAZO-PENDULAR MICROKERATOME (August 1, 2008)
  • K062465 — ZYOPTIX XP EPI SEPARATOR SYSTEM (September 6, 2006)
  • K052891 — HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM (March 23, 2006)
  • K051486 — NORWOOD ABBEY CENTURION SES EPIKERATOME (July 6, 2005)
  • K043183 — EPI-K (March 25, 2005)
  • K043150 — AMADEUS II EPIKERATOME (January 31, 2005)
  • K042083 — MODIFICATION TO VISITOME 20-10 MICROKERATOME (November 16, 2004)

FDA data resources