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Candela SPTL Variable Pulse/Tunable Pulsed Dye Lasers

by Candela Laser Corp.

510(k) K943292

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 NumberK943292 Date9 Mar 1995ClearedStatusActive

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  • Withdrawn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
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Candela SPTL Variable Pulse/Tunable Pulsed Dye Lasers is a powered laser surgical instrument used for vascular care. This device is designed to deliver variable pulse and tunable pulsed dye laser technology for medical applications.

The device is supplied by Candela Laser Corp. and has received FDA 510(k) clearance with product code GEX. It is classified as a powered laser surgical instrument and is intended for use in general and plastic surgery settings.

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