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Lamp Delivery Sys.-Photocoagulation

by Varian Assoc., Inc.

510(k) K772213

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 NumberK772213 Date13 Dec 1977ClearedStatusActive

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  • Withdrawn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
HQB
Device Class
Class II
Regulation
21 CFR Part 886.4690
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Lamp Delivery System - Photocoagulation is a photocoagulator and accessories device, classified as a class 2 device. It is used in ophthalmic applications.

The device is supplied as a lamp delivery system and is intended for use in photocoagulation procedures. It has been cleared by the FDA with a 510K number of K772213 and is regulated under regulation number 886.4690. The device is available with various accessories and is designed for use in ophthalmic settings.

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Questions

AI-generated answers, 1 Oct 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 Lamp Delivery System used for?

    The Lamp Delivery System is used in photocoagulation procedures for ophthalmic applications, providing a specific treatment option for patients.

  • Is the Lamp Delivery System supplied with accessories?

    Yes, the device is available with various accessories, designed to support its use in ophthalmic settings and procedures.

  • What is the regulatory status of the Lamp Delivery System?

    The device has been cleared by the FDA with a 510K number of K772213 and is regulated under regulation number 886.4690, indicating its compliance with relevant standards.