(106 days)
No
The device description and intended use focus on thermoelectric cooling/heating and massage functions, with no mention of AI or ML capabilities.
Yes
The device is described as "intended to temporarily relieve minor aches and pains and muscle spasms" and for "localized thermal therapy (hot or cold) to minimize pain for post traumatic and/or post surgical pain", which are therapeutic claims.
No
The device is described as a skin cooling and heating device for pain minimization, thermal injury prevention, and muscle relief, not for diagnosing medical conditions.
No
The device description explicitly states it is a "thermoelectric cooling and heating device" and includes an "electrically powered or pulsatile vacuum massage" function, indicating it is a hardware device with physical components.
Based on the provided information, the Zeltiq CLN1 Dermal Cooling Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for skin cooling, pain minimization during dermatological treatments, local anesthetic for minor discomfort, and localized thermal therapy for pain relief and muscle spasms. These are all applications directly on or to the patient's body.
- Device Description: The description details a thermoelectric device for applying controlled cooling or heating to a treatment site on the body, with an optional massage function.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body, not to directly treat or interact with the body itself in the way the Zeltiq CLN1 does.
N/A
Intended Use / Indications for Use
The Zeltiq CLN1 Dermal Cooling Device is intended for use as a skin cooling device to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort. The Zeltiq CLN1 Dermal Cooling Device can also provide localized thermal therapy (hot or cold) to minimize pain for post traumatic and/or post surgical pain and to temporarily relieve minor aches and pains and muscle spasms. The optional massage function can also be used for the temporary relief of minor muscle aches, pain, and spasm, for temporary improvement in local circulation and temporary reduction in the appearance of cellulite.
The Zeltig Coupling Gels facilitate thermal contact of the Zeltiq CLN1 Dermal Cooling Device with a patient's skin by mitigating minor variances in device-to-skin contact.
Product codes (comma separated list FDA assigned to the subject device)
79 GEX, 89 IOL, 89 ISA
Device Description
The Zeltiq CLN1 Dermal Cooling Device is a thermoelectric cooling and heating device that applies controlled cooling or heating to a treatment site. The device also includes the option of electrically powered or pulsatile vacuum massage.
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)
Testing confirms that the Zeltig CLN1 Dermal Cooling Device can be used in an equivalent manner to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
2. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT | Zeltiq Aesthetics, Inc.
4698 Willow Road
Pleasanton, CA 94588 | MAY - 2 2000 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| TRADE NAME: | Zeltiq Cooling Device | |
| COMMON NAME: | Skin Refrigerant | |
| CLASSIFICATION
NAME: | Laser instrument, surgical, powered | |
| DEVICE
CLASSIFICATION: | Class II, 21 CFR §878.4810 | |
| PRODUCT CODE | 79 GEX - laser instrument, surgical, powered
89 IOL - pack, hot or cold, water circulating
89 ISA - massager, therapeutic, electric | |
| PREDICATE DEVICE: | The Zeltiq CLN1 Dermal Cooling Device is substantially
equivalent in intended use and mechanism of action to the
Juniper CLN1 Dermal Cooling Device (K072152). The
device is also substantially equivalent to the Cynosure
Triactive Therapeutic massager (K030876) | |
SUBSTANTIALLY EQUIVALENT TO:
The Zeltiq CLN1 Dermal Cooling Device is substantially equivalent in intended use and mechanism of action to the Juniper CLN1 Dermal Cooling Device (K072152) and the Cynosure Triactive Therapeutic massager (K030876). The pager device used in the Zeltiq CLN1 Dermal Cooling Device is substantially equivalent to the Spacelabs Ultraview Waveform Pager System (K992749).
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Zeltiq CLN1 Dermal Cooling Device is a thermoelectric cooling and heating device that applies controlled cooling or heating to a treatment site. The device also includes the option of electrically powered or pulsatile vacuum massage.
1
80118 SECTION 7. 510(K) SUMMARY OF SAFETY AND EFFECT
INDICATION FOR USE:
The Zeltiq CLNI Dermal Cooling Device is intended for use as a skin cooling device to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort. The Zeltiq CLN1 Dermal Cooling Device can also provide localized thermal therapy (hot or cold) to minimize pain for post traumatic and/or post surgical pain and to temporarily relieve minor aches and pains and muscle spasms. The optional massage function can also be used for the temporary relief of minor muscle aches, pain, and spasm, for temporary improvement in local circulation and temporary reduction in the appearance of cellulite.
The Zeltiq Coupling Gels facilitate thermal contact of the Zeltig CLN1 Dermal Cooling Device with a patient's skin by mitigating minor variances in device-to-skin contact.
TECHNICAL CHARACTERISTICS:
The Zeltiq CLN1 Dermal Cooling Device is a thermoelectric cooling and heating device that applies controlled cooling or heating to a treatment site. The optional massage feature uses electrically powered vibration or pulsatile vacuum, depending on the applicator.
PERFORMANCE DATA:
Testing confirms that the Zeltig CLN1 Dermal Cooling Device can be used in an equivalent manner to the predicate devices.
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
The indications for use for the Zeltiq CLN1 Dermal Cooling Device are the same as for the predicate devices cited in this application. A technological comparison and bench testing demonstrate that the Zeltiq CLN1 Dermal Cooling Device is functionally equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 2008
Zeltiq Aesthetics % Mr. Donald V. Johnson VP, Operations, Quality and Regulatory Affairs 4698 Willow Road Pleasanton, California 94588
Re: K080118
Trade/Device Name: Zeltiq CLN1 Dermal Cooling Device 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: April 25, 2008 Received: April 28, 2008
Dear Mr. Johnson:
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 such 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); good manufacturing practice requirements as set
3
Page 2 – Mr. Donald V. Johnson
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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 postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.
Mark N. Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
- INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Zeltiq CLN1 Dermal Cooling Device
Indications for Use:
The Zeltiq CLN1 Dermal Cooling Device is intended for use as a skin cooling device to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort. The Zeltiq CLN1 Dermal Cooling Device can also provide localized thermal therapy (hot or cold) to minimize pain for post traumatic and/or post surgical pain and to temporarily relieve minor aches and pains and muscle spasms. The optional massage function can also be used for the temporary relief of minor muscle aches, pain, and spasm, for temporary improvement in local circulation and temporary reduction in the appearance of cellulite.
The Zeltig Coupling Gels facilitate thermal contact of the Zeltiq CLN1 Dermal Cooling Device with a patient's skin by mitigating minor variances in device-to-skin contact.
Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. de Grasse Tyson
(Division Sign-Division of General, Restorative, and Neurological Devices
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510(k) Number K080118
CONFIDENTIAL