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D.O.R.C. Microdiathermy System

by Dutch Ophthalmic USA, Inc. 510(k)

Active United States

510(k) K962135

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK962135 Date29 Aug 1996ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HQO
Device Class
Class II
Regulation
21 CFR Part 886.4115
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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