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Therapeutic Ultrasound for Treatment of Glaucoma

by Sonocare, Inc.

PMA P860046

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P860046↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP860046 Date30 Jun 1988ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Generic Name
Ultrasound, cyclodestructive
PMA Number
FDA Product Code
LZR
Device Class
Class II
Regulation
21 CFR Part 886.5350
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 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 Therapeutic Ultrasound for Treatment of Glaucoma is an ophthalmic device that uses ultrasound cyclodestructive technology to treat glaucoma. It delivers therapeutic ultrasound energy to target specific eye tissues involved in glaucoma management.

This device is supplied by Sonocare, Inc. and is authorized under FDA PMA number P860046. It is a Class II medical device regulated under 886.5350, designed for use in ophthalmic settings to provide cyclodestructive treatment for glaucoma patients.

Other devices from Sonocare, Inc.

  • Model Stt-100

    Class II

Questions

AI-generated answers, 18 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 Therapeutic Ultrasound for Treatment of Glaucoma used for?

    This device uses ultrasound cyclodestructive technology to treat glaucoma by delivering therapeutic ultrasound energy to target specific eye tissues involved in glaucoma management.

  • How is the Therapeutic Ultrasound device supplied?

    The device is supplied by Sonocare, Inc. and is designed for use in ophthalmic settings to provide cyclodestructive treatment for glaucoma patients.

  • What is the regulatory status of this device?

    The device is authorized under FDA PMA number P860046 and is a Class II medical device regulated under 886.5350.

  • Is this device single-use or reusable?

    The device data does not specify whether it is single-use or reusable, so this information is not available from the provided information.