D.O.R.C. VFI/VFE SYSTEM

• K Number: K954842
• Device Name: D.O.R.C. VFI/VFE SYSTEM
• Manufacturer: DUTCH OPHTHALMIC USA, INC.
• Date Cleared: 1996-04-15 ( 175 days)
• Product Code: KYG
• Regulation Number: 886.4360
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 886.4360 Ocular surgery irrigation device.

(a)
Identification. An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.