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Solos Single Use Titanium Tip

by Solos Ophthalmology

510(k) K874334

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 NumberK874334 Date11 Jan 1988ClearedStatusActive

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  • Withdrawn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, 21 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 Solos Single Use Titanium Tip is a phacofragmentation unit component. It is designed for use as part of a phacofragmentation system to assist in the disruption and extraction of cataracts during ophthalmic surgery.

This device is supplied for single use and is regulated under FDA 510(k) clearance number K874334. It is classified as a Class 2 ophthalmic device under regulation number 886.4670.

Other devices from Solos Ophthalmology

Questions

AI-generated answers, 21 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 primary purpose of the Solos Single Use Titanium Tip?

    This device is a component of a phacofragmentation system. It is specifically designed to assist surgeons in the disruption and extraction of cataracts during ophthalmic surgical procedures.

  • Is this device intended for reuse?

    No, the device is supplied for single use only. It should be disposed of after the surgical procedure to ensure patient safety and maintain the integrity of the instrument.

  • What is the regulatory status of this device?

    The Solos Single Use Titanium Tip is regulated under FDA 510(k) clearance number K874334. It is classified as a Class 2 ophthalmic device under regulation number 886.4670.