← Product Code [HKP](/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP) · K952558

# AARON VAC 2 (K952558)

_Aaron Medical Industries · HKP · Mar 19, 1997 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP/K952558

## Device Facts

- **Applicant:** Aaron Medical Industries
- **Product Code:** [HKP](/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP.md)
- **Decision Date:** Mar 19, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.4150
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory 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.

## Special Controls

*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.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP/K952558](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP/K952558)

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