ANDELA DYNAMIC COOLING DEVICE

K951033 · Candela Laser Corp. · IMD · Aug 15, 1996 · Physical Medicine

Device Facts

• Record ID: K951033
• Device Name: ANDELA DYNAMIC COOLING DEVICE
• Applicant: Candela Laser Corp.
• Product Code: IMD · Physical Medicine
• Decision Date: Aug 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5710
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The intended use of the Candela Dynamic Cooling Device is to minimize thermal injury to non-vascular skin structures during laser therapy of benign cutaneous vascular lesions, and to reduce pain associated with laser treatment.

Device Story

Device consists of CFC R-12 refrigerant source, electronically controlled solenoid delivery valve, and electronic timing circuitry. Integrated with SPTL laser triggerswitch system; delivers pulsed spray of CFC R-12 immediately preceding laser pulse. Evaporative cooling minimizes thermal injury to non-vascular skin structures and reduces pain. Used in clinical dermatology settings by physicians. Output is controlled refrigerant spray; assists clinical decision-making by enabling safer laser application; benefits patient via reduced pain and thermal damage.

Clinical Evidence

Bench testing only. Performance assessed via dimensional testing, functional properties, intended use verification, ease of use, and durability testing. No clinical data provided.

Technological Characteristics

Components: CFC R-12 refrigerant, solenoid delivery valve, electronic timing circuitry. Connectivity: In-line integration with SPTL laser triggerswitch. Principle: Evaporative cooling via pulsed refrigerant spray.

Indications for Use

Indicated for patients undergoing laser therapy for benign cutaneous vascular lesions to minimize thermal injury to non-vascular skin structures and reduce treatment-associated pain.

Regulatory Classification

Identification

A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.

Predicate Devices

• Cool Laser Optics Device
• Cold Packs

Submission Summary (Full Text)

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510(k) Premarket Notification: Candela Dynamic Cooling Device for SPTL Lasers

AUG 15 1996

K951033

# CANDELA DYNAMIC COOLING DEVICE
## 510(k) SUMMARY

## GENERAL INFORMATION

Classification: Laser Surgical Instrument Accessory for use in General and Plastic Surgery and in Dermatology

Common Name: Skin refrigerant

Predicate Device: Cool Laser Optics Device and numerous Cold Packs

## DESCRIPTION

Candela's Dynamic Cooling Device consists of 1) a source of skin refrigerant fluid (CFC R-12), 2) an electronically controlled solenoid delivery valve, and 3) electronic timing circuitry. The Dynamic Cooling Device is connected in line with an SPTL laser's triggerswitch system so that activation of the triggerswitch controls the delivery of a pulsed spray of CFC R-12 just prior to the delivery of a laser pulse. The pulsed spray of skin refrigerant cools the skin as it evaporates. Thermal injury to non-vascular structures is minimized and pain associated with the laser treatment is reduced.

## INTENDED USE STATEMENT

The intended use of the Candela Dynamic Cooling Device is to minimize thermal injury to non-vascular skin structures during laser therapy of benign cutaneous vascular lesions, and to reduce pain associated with laser treatment.

## TESTING

Candela's Dynamic Cooling Device has undergone and passed testing during its development designed to assess the performance of components and finished devices, including dimensional testing, functional properties, function according to its intended use, ease of use and durability.

## PRODUCT DEVELOPMENT REVIEW

Design reviews conducted during development of this device verify the appropriateness of materials and design selection.

## SUMMARY OF SUBSTANTIAL EQUIVALENCE

Candela's Dynamic Cooling Device is substantially equivalent to the Cool Laser Optics device and to numerous legally marketed Cold Packs on the basis of similarities in operating principles, intended use and functional performance.

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