(126 days)
Not Found
No
The summary describes a thermoelectric cooling/heating device with optional massage and paging functions. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is intended to minimize pain, relieve minor aches and pains and muscle spasms, and improve local circulation, which are all therapeutic benefits.
No
The device is used for cooling and heating the skin to minimize pain, thermal injury, and muscle spasms, and to improve circulation. It is not described as diagnosing any conditions or analyzing data to provide a medical diagnosis.
No
The device description explicitly states it is a "thermoelectric cooling and heating device" and includes hardware components like a massage function and an optional paging device, indicating it is not solely software.
Based on the provided information, the Zeltiq System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for skin cooling and thermal therapy during laser and dermatological treatments, as well as for pain relief and muscle issues. These are all applications that involve direct interaction with the patient's body and do not involve testing samples of biological material in vitro (outside the body).
- Device Description: The description details a thermoelectric cooling and heating device with optional massage. This aligns with a physical therapy or dermatological treatment device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the Zeltiq System falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Zeltig System 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 System 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.
Product codes (comma separated list FDA assigned to the subject device)
79 GEX, 89 IOL, 89 ISA
Device Description
The Zeltig System 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 and an optional paging device.
The Zeltiq System 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. The system includes an optional paging device.
Zeltiq Gel facilitates thermal contact of the Zeltiq System with a patient's skin by mitigating minor variances in device-to-skin contact.
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 Zeltiq System can be used in an equivalent manner to the predicate device.
A technological comparison and bench testing demonstrate that the Zeltiq System is functionally equivalent to the predicate device.
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.
Not Found
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
Ko90094
510(K) SUMMARY OF SAFETY AND EFFECTIVE SECTION 6.
6. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
r
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 20 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------|
| TRADE NAME: | Zeltiq System | |
| 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 System is substantially equivalent to the Zeltiq
CLN1 Dermal Cooling Device (K080118) | |
SUBSTANTIALLY EQUIVALENT TO:
The Zeltig System has the same intended use and mechanism of action to the Zeltig CLN1 Dermal Cooling Device (K080118).
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Zeltig System 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 and an optional paging device.
INDICATION FOR USE:
The Zeltig System 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 System 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.
2009
1
Ko 0.094
Page 2 of 2
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 6.
Zeltig Gel facilitates thermal contact of the Zeltiq System with a patient's skin by mitigating minor variances in device-to-skin contact.
TECHNICAL CHARACTERISTICS:
The Zeltiq System 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. The system includes an optional paging device.
PERFORMANCE DATA:
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Testing confirms that the Zeltiq System can be used in an equivalent manner to the predicate device.
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
The indications for use for the Zeltiq System are the same as for the predicate device cited in this application. A technological comparison and bench testing demonstrate that the Zeltiq System is functionally equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Public Health Service
MAY 20 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zeltiq System % Mr. Donald V. Johnson VP. Operations, Regulatory and Quality Affairs 4698 Willow Road Pleasanton, California 94588
Re: K090094
Trade/Device Name: Zeltiq System 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, ILO, ISA Dated: May 7, 2009 Received: May 11, 2009
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.
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.
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
3
Page 2 - Mr. Donald V. Johnson
(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 N. Melkerson
Division of Surgical, Orthopedic
and Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
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Enclosure
4
SECTION 5.
INDICATIONS FOR USE STATEMENT
ડ. INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Zeltig System
Indications for Use:
The Zeltig System 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 Zeltig System 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.
90094
Zeltiq Gel facilitates thermal contact of the Zeltiq System 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)
Neile Roplem formkin
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page of
510(k) Number K.090014
K0900094 S-1