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510(k) K011498

EASY CONTROL MICRO INSERTER, MODEL ON385 by Ophtec USA, Inc. — Product Code NCE

K011498 is an FDA 510(k) premarket notification submitted by Ophtec USA, Inc. for the device "EASY CONTROL MICRO INSERTER, MODEL ON385". The FDA issued a decision of Substantially Equivalent on July 9, 2001. The device falls under product code NCE (Injector, Capsular Tension Ring), a Class I device regulated under 21 CFR 886.4300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2001
Date Received
May 15, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Capsular Tension Ring
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type

Other clearances for product code NCE

  • K042478 — CAPSULE TENSION RING INSERTER, MODEL 7-810 (December 28, 2004)
  • K001125 — GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING (October 4, 2000)

FDA data resources