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Site Ultrasonic Emulsification Module OP

by Chiron Vision Corp.

510(k) K844666

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK844666 Date27 Dec 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HQC
Device Class
Class II
Regulation
21 CFR Part 886.4670
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Site Ultrasonic Emulsification Module OP is a unit used for phacofragmentation in ophthalmic procedures. It is classified as a Class II medical device under FDA regulation number 886.4670.

This device received FDA 510(k) clearance (K844666) on December 27, 1984, as substantially equivalent to a predicate device. It is manufactured by Chiron Vision Corp. and assigned product code HQC.

Other devices from Chiron Vision Corp.

See all devices from Chiron Vision Corp. →

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Site Ultrasonic Emulsification Module OP used for?

    It is used for phacofragmentation in ophthalmic procedures in ophthalmic surgery, where it emulsifies and removes the cataractous lens using ultrasonic energy during cataract extraction.

  • How is the Site Ultrasonic Emulsification Module OP supplied and is it reusable?

    The device is supplied as a reusable unit designed for multiple uses in clinical settings; it is not a single-use device and requires proper cleaning, disinfection, and maintenance between procedures according to manufacturer guidelines.

  • What regulatory pathway was used for the Site Ultrasonic Emulsification Module OP?

    It received FDA 510(k) clearance under K844666 on December 27, 1984, demonstrating substantial equivalence to a legally marketed predicate device under regulation number 886.4670 for ophthalmic ultrasonic phacofragmentation units.