510(k) K991124

Device: VISIJET HYDROKERATOME, MODEL 50
Applicant: VISIJET, INC.
510(k) number: K991124
Product code: MYD
Decision: Substantially Equivalent (SESE)
Decision date: 2000-10-20
Date received: 1999-04-02
Regulation: 886.4370
Classification name: Keratome, Water Jet
Medical specialty: Ophthalmic
Review panel: Ophthalmic
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Related Records

Product code MYD
Company: VISIJET, INC.
21 CFR 886.4370

Applicant Contact

Contact: JUDY F GORDON
Address: 18732 Saginaw Irvine CA US 92614 92614

Source Documents

510(k) summary PDF

Legacy Summary

summary

FDA Review

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