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Model 10-C W/Fl-10A/U Optical Attachment/Opthalmic

by Directed Energy, Inc. 510(k)

Active United States

510(k) K870839

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK870839 Date22 May 1987ClearedStatusActive

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  • Withdrawn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 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HQF
Device Class
Class II
Regulation
21 CFR Part 886.4390
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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