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510(k) K013760

DC-3300 LASER DIODE PHOTOCOAGULATOR by Nidek, Inc. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2002
Date Received
November 13, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type

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  • K013864 — MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 (February 8, 2002)
  • K990119 — EPI-STAR SURGICAL LASER SYSTER (July 27, 2000)
  • K990900 — MICROKERATOME, MODEL MK-2000 (September 24, 1999)

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