Skip to content

Ip System, Oculab Ip, Optomize Ip, Retasure Ip

by Digital Healthcare, Ltd. 510(k)

Active United States

510(k) K071299

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK071299 Date31 Aug 2007ClearedStatusActive

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  • Withdrawn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
NFJ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent