(22 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, nor does it describe features or processes that typically involve AI/ML, such as image processing or data analysis for diagnostic or predictive purposes.
Yes
The device's intended use explicitly states "Non-invasive treatment of periorbital wrinkles and rhytids" and "Non-invasive treatment of facial wrinkles and rhytids," which are therapeutic applications.
No
This device is indicated for treatment procedures like electrocoagulation and hemostasis, and the non-invasive treatment of wrinkles, not for diagnostic purposes.
No
The device description clearly lists multiple hardware components including a system unit, handpiece assembly, accessories, cables, tubing, and an optional footswitch. This indicates it is a hardware-based system, not software-only.
Based on the provided information, the Thermage ThermaCool System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes procedures performed on the patient's body (electrocoagulation, hemostasis, treatment of wrinkles). IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The components listed are for delivering energy to the skin and surrounding tissues, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components of an IVD.
Therefore, the Thermage ThermaCool System is a therapeutic device used for dermatological and surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Thermage ThermaCool System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis. Non-invasive Sonehal of periorbital wrinkles and rhytids. Non-invasive treatment of facial wrinkles and rhytids.
Product codes
GEI
Device Description
The Thermage ThermaCool System consists of the following components:
- ThermaCool System .
- Handpiece Assembly (consisting of Handpiece and Treatment Tip) ●
- Accessories: Coolant Canister, Coupling Fluid, Return Pad and Skin . Marking Paper
- Accessory cables and tubing .
- Optional footswitch component .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital, facial
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
051710
510(k) Safety Summary 14.0
Name of Device A.
| Trade Name: | Thermage ThermaCool System |
|---|---|
| Common Name: | Electrosurgical Unit and Accessories |
| Classification Name: | Device, Electrosurgical Cutting and Coagulation and |
| Accessories (21 CFR 878.4400) | |
| Contact Person: | Pamela M. Buckman, RN, MS |
| Vice President of Regulatory/Clinical Affairs |
Predicate Devices B.
The predicate device for the ThermaCool Coupling Fluid that is the subject of this 510(k) is:
| Accessory | Predicate | Premarket Notification |
|---|---|---|
| Coupling Fluid | ThermaCool Coupling Fluid TF-2 | K033942, Cleared 2/4/04 |
Device Description C.
The Thermage ThermaCool System consists of the following components:
- ThermaCool System .
- Handpiece Assembly (consisting of Handpiece and Treatment Tip) ●
- Accessories: Coolant Canister, Coupling Fluid, Return Pad and Skin . Marking Paper
- Accessory cables and tubing .
- Optional footswitch component .
1
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D. Indicated Use
The Thermage ThermaCool System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis. Non-invasive Sonehal of periorbital wrinkles and rhytids. Non-invasive treatment of facial wrinkles and rhytids.
Technical characteristics E.
The technological characteristics of the ThermaCool Coupling Fluid is substantially equivalent to those of the predicate device.
F. Summary
By virtue of design, principle of operation, materials and intended use, the Thermage ThermaCool Coupling Fluid is substantially equivalent to devices currently cleared for marketing in the United States.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/13 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 words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Pamela M. Buckman, RN, MS VP Clinical/Regulatory Thermage, Inc. 4058 Point Eden Way Hayward, California 94545-3721
Re: K051710
Trade/Device Name: Thermage ThermaCool System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI
Dated: July 7, 2005 Received: July 8, 2005
Dear Ms. Buckman:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section - Forty premained in substantially equivalent (for the indications referenced above and nave uctchillied the devices marketed in interstate for use stated in the encrosule for legally manities in the Medical Device Amendments, or to commerce prior to May 28, 1776, the enactions and the Federal Food. Drug. devices that have been reclassified in accenance with the providions of the Act. The and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The
You may, therefore, market the device, subject to the general masistentian, You may, merelore, market the dovres, belyer to in of any in any intereststration, listing of
general controls provisions of the Act include requirements for any interestran general controls provisions of the fret mercials requires against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classifica (see above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Entrolling Component of Commons, Time of September of be found in the Code of Peachar Regerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualited of a backan and mith other requirements of the Act
that FDA has made a determination that your device complies with other requirements that FDA has inade a determination administered by other Federal agencies. You must of any Federal statutes and regulations adminders on thot limited to: registration and listing (21 l comply with an the Act 31cquiroments, merceing, and manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820), good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820), and 11 app 1050 forum in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
JUL 1 9 2005
3
Page 2-Ms.Pamela M. Buckman, RN, MS
This letter will allow you to begin marketing your device as described in your Section 10(k) This letter will anow you to begin mailing of substantial equivalence of your device to a legally premarket nothcation. THC PDA miding of backed on 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 If you desire specific advice for your ac now on 5. Also, please note the regulation entitled,
contact the Office of Compliance at (240) 276-0115. Also, please note Colliation of Compulation and (21 the Part 807.97). You may obtain Misorahung by icierchoe to premainsonsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provo
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Koś 1710
Not Known 510(k) NUMBER (IF KNOWN):
Thermage ThermaCool System DEVICE NAME: INDICATIONS FOR USE: ستقرميترت التق
The Thermage ThermaCool System is indicated for use in:
- Dermatologic and general surgical procedures for electro coagulation and u hemostasis,
- Non-invasive treatment of periorbital wrinkles and rhytids u
- Non-invasive treatment of facial wrinkles and rhytids
| Prescription Use | X | OR | Over-The-Counter-Use | ||
|---|---|---|---|---|---|
| (Per 21 CFR 801.109) | |||||
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||||
| (Division Sign- | |||||
| Division of Ger 1. Restorative | |||||
| and from J. J. Devices | |||||
| 510(k) Number: K051710 |
Thermage ThermaCool Coupling Fluid 510(k)