This device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections.

Device Description

COOLSKIN is a 14" by 16" by 2 ¾ ft, 66 lb thermo-cooling mobile device that applies controlled cooling in the range of 3 degrees F to 50 degrees F (-16 degrees C to 10 degrees C) at skin surface in order to decrease skin temperature via a probe which is in direct contact with the skin surface. The device operates by semiconductor using Peltier principle. While the proximal side (towards the skin surface) gets cold, the distal side gets hot. The hot side is cooled by a water cooling system, which runs to the probe tip via a water circulating tube, and cools it. The warm/hot water is channeled away to the main unit where it is cooled via a fan. The probe is available in small and large versions.

AI/ML Overview

This document does not contain the information required to fulfill the request. The provided text is a 510(k) summary for a skin cooling device (COOLSKIN), which primarily focuses on establishing substantial equivalence to a predicate device. It does not include details about acceptance criteria, a specific study proving those criteria were met, sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

The document states:

"COOLSKIN is safe and effective as the predicate device cited above."
"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...".

This indicates the device's clearance was based on demonstrating equivalence, not necessarily on a detailed performance study with defined acceptance criteria as described in the prompt's requirements.

Summary

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510(k) Summary

As Required by 21 section 807.92 ( c )

1-Submitter Name: Elbio Co. Ltd 2-Address: 517 World Meridian Venture Center II 426-5 Gasan-dong, Geumchun-qu,

Seoul, Korea

3-Phone: 82-2-744-7770 (206)

82-2-744-2220 4-Fax:

Mr Youngsam Chun (President) 5-Contact Person:

6-Date summary prepared: May 24th, 2009

7 - Official Correspondent: Mansour Consulting LLC

8- Address: 845 Aronson Lake Court. Roswell, GA 30075 USA

9- Phone: 678-908-8180
10- Fax: 678-623-3765

11- Contact Person: Jay Mansour, President

12-Device Trade or Proprietary Name: COOLSKIN

13-Device Common or usual name: Skin cooling device

14-Device Classification Name: pack, cold, water circulating

15-Substantial Equivalency is claimed against Cryo V6.0, cleared under K060395

16-Description of the Device:

17-Intended use of the device: {refer to FDA form attached}

This device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections.

18-Safety and Effectiveness of the device:

COOLSKIN is safe and effective as the predicate device cited above.

Page 7 (revised)

JUN 1 0 2009

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Elbio Company, Limited % Mansour Consulting LLC Mr. Jay Mansour President 845 Aronson Lake Court Roswell, Georgia 30075

JUN 1 0 2004

Re: K083008

Trade/Device Name: COOLSKIN Regulation Number: 21 CFR 890.5720 Regulation Name: Water Circulation Hot or Cold Pack Regulatory Class: II Product Code: ILO Dated: May 24, 2009 Received: June 3, 2009

Dear Mr. Mansour:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting

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Page 2-Mr. Jay Mansour

(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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p. [otf|

Indications for Use

510(k) Number (if known): K083008

Device Name: COOLSKIN

Indications For Use:

This device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogle for mxm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K083008

Regulation Number and Section

§ 890.5720 Water circulating hot or cold pack.

(a)
Identification. A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.