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Biomicroscopy Contact Lens

by Design Research Assoc., Inc. 510(k)

Active United States

510(k) K813313

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK813313 Date1 Mar 1982ClearedStatusActive

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  • Withdrawn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
HJO
Device Class
Class II
Regulation
21 CFR Part 886.1850
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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