(245 days)
Not Found
No
The description focuses on the physical mechanism of cooling (Peltier principle, water cooling, fan) and does not mention any computational or algorithmic processes indicative of AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is intended to "minimize pain" and provide "temporary topical anesthetic relief," which are therapeutic effects.
No
The device is described as a "thermo-cooling mobile device" intended to "minimize pain and thermal injury" and provide "temporary topical anesthetic relief." Its function is to apply controlled cooling to the skin surface. This is a therapeutic or comfort-enhancing function, not a diagnostic one. It does not identify, assess, or monitor a disease or condition.
No
The device description clearly details a physical, mobile device with specific dimensions, weight, and hardware components (thermo-cooling unit, probe, water cooling system, fan). It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections. This involves direct application to the patient's skin for therapeutic and comfort purposes.
- Device Description: The device is a physical cooling unit that applies controlled temperature to the skin surface. It does not analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information about a disease or condition.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic results.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
ILO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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:
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.
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
1
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
2
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
3
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