# K993671: Candela Sclero Long Pulse Dye Laser

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Jan 24, 2000 after 84 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K904627 (1991). 27 ancestors in all.
700 later devices descend from it; 1 cites it directly.
0 of 728 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954934: Candela SPTL Long Pulse/Tunable Pulsed Dye Lase, Candela Laser Corp. (1996) Summary page 1.
- K931762: Candela SPTL Pulsed Dye Lasers, Candela Laser Corp. (1994) Summary page 1.
- K882160: Coherent System 920 Argon/Dye Photocoagulator, Coherent Medical Lasers (1988) Summary page 1.
- K971737: Cynosure Photogenica Lpir Dermatological Laser, Cynosure, Inc. (1997) Summary page 1.
- K972347: Modified Coherent Versapulse Aesthetic Surgical Laser, Lumenis, Inc. (1997) Summary page 1.
- K981952: Combination ND:Yag and Frequency Doubled Solid State Green Laser, Instruments For Medicine and Diagnostics (1998) Summary page 1.
- K991234: The Acme Medical Aesthetic ND:Yag Laser, Acme Medical, Inc. (1999) Summary page 1.

## Most influential descendants
- K013748: Candela Sclero Long Pulse Laser (Aka Vbeam) (2002), 699 descendants of its own
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models (2002), 665 descendants of its own
- K033251: The Friendlylight ND: Yag Lasers (2004), 519 descendants of its own
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K021180: Candela Vbeam Pulsed Dye Laser System (2002), 318 descendants of its own

## Indications for use
The Candela Sclero Long Pulse Laser is indicated for the following uses: General Surgery: Photocoagulation of benign cutaneous vascular lesion and benign cutaneous lesions. Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesion, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma;, spider angioma, poikiloderma of Civatte and benign cutaneous lesion, such as warts, scars, striae. Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology Podiatry: Treatment of benign cutaneous lesion, such as warts. The Candela Sclero Long Pulse Laser includes an integrated Dynamic Cooling Device, which is indicated for: 1. the reduction in pain. 2. cooling of the skin prior to laser treatment

Source page: https://510kreport.com/device/K993671
Methodology: https://510kreport.com/methodology