(187 days)
Not Found
No
The document describes a radiofrequency (RF) generator system for electrocoagulation and wrinkle treatment, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is indicated for "Non-invasive treatment of periorbital wrinkles and rhytids" which describes a therapeutic use for a medical condition.
No
The device description indicates it is used for "electrocoagulation and hemostasis" and "non-invasive treatment of periorbital wrinkles and rhytids," which are therapeutic rather than diagnostic applications.
No
The device description explicitly lists multiple hardware components including an RF Generator, Cooling Module, Cryogen Canister, Handpiece Assembly, cables, tubing, and an optional footswitch.
Based on the provided information, the Thermage ThermaCool TC System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states "Dermatologic and general surgical procedures for electrocoagulation and hemostasis, Non-invasive treatment of periorbital wrinkles and rhytids." This describes a device used on the patient's body for therapeutic and surgical purposes.
- Device Description: The components listed (RF Generator, Cooling Module, Handpiece, etc.) are consistent with a device that delivers energy to tissue, not one that analyzes biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Thermage ThermaCool TC System does not fit this description.
N/A
Intended Use / Indications for Use
The Thermage ThermaCool TC System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis; noninvasive treatment of periorbital wrinkles and rhytids.
Product codes
GEI
Device Description
The Thermage ThermaCool TC System consists of the following components:
- RF Generator
- Cooling Module ●
- Cryogen Canister .
- Handpiece Assembly (consisting of Handpiece and Treatment Tip) ●
- . Accessory cables and tubing
- Optional footswitch component .
- Accessories: coupling fluid, return pad and skin marking paper .
The Handpiece Assembly and Cooling Module connect to the RF Generator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital
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)
K000944, K003183, K013034 (S), K013639
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
021402
5 2002 NOV
2
14.0 510(k) Safety Summary
,
A. Name of Device
| Trade Name: | Thermage ThermaCool TC System (Model TC) |
|---|---|
| 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 |
| Sr. Director of Regulatory/Clinical Affairs |
B. Predicate Devices
ThermaCool TC System (including Cryogen canister and footswitch);
| 510 (k) Number | Name of Device | Decision Date |
|---|---|---|
| K000944 | ThermaCool | July 19, 2000 |
| K003183 | ThermaCool II | December 8, 2000 |
| K013034 (S) | ThermaCool IIA | October 4, 2001 |
| K013639 | ThermaCool TC | January 29, 2002 |
Other ThermaCool TC System Accessories (return pad, coupling fluid and skin marking paper):
| Accessory | Predicate | Premarket Notification |
|---|---|---|
| Return Pad | Nikomed Electrosurgical | |
| Grounding Pad | K000079, Cleared 2/4/00 | |
| Coupling Fluid | Cadwell Lectron II | K933804, Cleared 3/22/94 |
| Skin Marking | ||
| Paper | Skin Marker | Class I, Exempt (878.4660) |
C. Device Description
The Thermage ThermaCool TC System consists of the following components:
1
021402 4/2
- RF Generator
- Cooling Module ●
- Cryogen Canister .
- Handpiece Assembly (consisting of Handpiece and Treatment Tip) ●
- . Accessory cables and tubing
- Optional footswitch component .
- Accessories: coupling fluid, return pad and skin marking paper .
The Handpiece Assembly and Cooling Module connect to the RF Generator.
D. Indicated Use
The Thermage ThermaCool TC System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis; noninvasive treatment of periorbital wrinkles and rhytids.
E. Technical characteristics
The technological characteristics and clinical use data of the Thermage ThermaCool TC System for the expanded indication are substantially equivalent to those of ThermaCool II System, and the previously cleared ThermaCool TC System.
F. Summary
By virtue of design, principle of operation, materials and intended use, the Thermage ThermaCool TC System is substantially equivalent to devices currently cleared for marketing in the United States.
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is black and the background is white. The text is centered in the image.
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle are three stylized human profiles facing to the right, stacked one behind the other.
NOV 5 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Pamela M. Buckman, R.N., M.S. Senior Director of Regulatory/Clinical Affairs Thermage 4058 Point Eden Way Hayward, California 94545
Re: K021402
Trade/Device Name: Thermage ThermaCool TC System (Model TC) Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 5, 2002 Received: August 6, 2002
Dear Ms. Buckman:
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 setforth 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.
3
Page 2 – Ms. Pamela M. Buckman
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the . regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Co Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Not Known 510(k) NUMBER (IF KNOWN):
DEVICE NAME: Thermage ThermaCool TC System (Model TC)
INDICATIONS FOR USE:
The Thermage ThermaCool TC System (Model TC) is indicated for use in:
Dermatologic and general surgical procedures for electrocoagulation and hemostasis,
Non-invasive treatment of periorbital wrinkles and rhytids ﻨﻪ ﺳ
Miriam C. Provost
(Division Sign-Off) (Division Sign-Oir)
Division of General, Restorative Division ological Devices
510(k) Number K 021402
Thermage ThermaCool TC System 510(k)