(36 days)
Not Found
No
The device description and lack of mention of AI/ML terms or performance studies related to algorithms indicate it is a simple refrigeration and air delivery system.
Yes
The device is intended to minimize pain and provide temporary topical anesthetic relief, which are therapeutic effects.
No
The device's intended use is to minimize pain and thermal injury and provide topical anesthetic relief, which are therapeutic and palliative functions, not diagnostic.
No
The device description explicitly states it consists of a "refrigeration unit" and an "air hose," which are hardware components.
Based on the provided information, the SmartCool family cold air 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. This is a therapeutic and pain management application, not a diagnostic one.
- Device Description: The device description clearly states it's a refrigeration unit that blows cold air onto the skin. This is a physical therapy/treatment device, not something that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests to diagnose conditions, or providing information about a patient's health status based on in vitro analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SmartCool device does not fit this description.
N/A
Intended Use / Indications for Use
The SmartCool family cold air device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief.
Product codes
GEX
Device Description
The SmartCool family cold air device consists of a refrigeration unit that creates cold air. The cold air is blown onto the skin using an air hose.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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)
Nonclinical Performance Data: none
Clinical Performance Data: none
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
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
K090618
Page 1 of 1
APR 1:4 2009
510(K) Summary
| Submitter: | Cynosure, Inc.
5 Carlisle Road
Westford, MA 01886 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho
Senior Vice President of Medical Technology and Regulatory Affairs |
| Date Summary Prepared:
Device Trade Name: | March 6, 2009
Cynosure SmartCool family cold air device |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser
Class II (21 CFR 878.4810) |
| Equivalent Device: | Cryo 5 (K040727), Cryo V6 (K060395), and CryoMini (K080735) |
| Device Description: | The SmartCool family cold air device consists of a refrigeration unit
that creates cold air. The cold air is blown onto the skin using an air
hose. |
| Intended Use: | The SmartCool family cold air device is intended to minimize pain and
thermal injury during laser and dermatological treatments and for
temporary topical anesthetic relief. |
| Comparison: | The SmartCool family cold air device has the same indications for use,
the same principle of operation, and the same performance as the
predicate device(s). |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The SmartCool family cold air device is a safe and effective device for
the 'indications for use' specified. |
| Additional Information: | none |
ﺮ
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/15 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized depiction of an eagle. The eagle is facing to the right and has three stripes across its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 -
APR 1 4 2009
Cynosure, Inc. % Mr. George Cho Senior Vice President of Medical Technology and Regulatory Affairs 5 Carlisle Road Westford, Massachusetts 01886
Re: K090618
Trade/Device Name: Cynosure SmartCool Family Cold Air Device: SmartCool, SmartCool 6, and Cryo C
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: II
Product Code: GEX Dated: March 6, 2009 Received: March 9, 2009
Dear Mr. Cho:
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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. George Cho
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 M. Milkenan
Mark N. Melkerson Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
090618
Page 1 of 1
510(k) Number (if known):
Device Name: Cynosure SmartCool Family Cold Air Device: SmartCool, SmartCool 6,
and Cryo C.
Indications For Use:
The SmartCool family cold air device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief.
Prescriptive Use X OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nilkeoph formx
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Ko10618 510(k) Number_