D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM

• K Number: K010082
• Device Name: D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM
• Manufacturer: DUTCH OPHTHALMIC USA, INC.
• Date Cleared: 2001-03-12 ( 61 days)
• Product Code: HQE
• Regulation Number: 886.4150
• 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

§ 886.4150 Vitreous aspiration and cutting instrument.

(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.