(35 days)
Not Found
No
The document describes a radiofrequency energy delivery system for dermatological procedures and makes no mention of AI or ML technologies.
Yes
The "Intended Use / Indications for Use" section explicitly states "Non-invasive treatment of periorbital wrinkles and rhytids" and "Non-invasive treatment of facial wrinkles and rhytids," which are therapeutic applications.
No
The device's intended use is for dermatologic electrocoagulation, hemostasis, and non-invasive treatment of wrinkles, which are therapeutic rather than diagnostic actions.
No
The device description explicitly lists multiple hardware components including a system unit, handpiece assembly, accessories (coolant canister, coupling fluid, return pad, skin marking paper), 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 In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes the device being used for dermatologic electrocoagulation, hemostasis, and the non-invasive treatment of wrinkles and rhytids. These are all procedures performed directly on the patient's body.
- Device Description: The components listed (system, handpiece, tips, coolant, etc.) are consistent with a device used for applying energy to tissue, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to be used in vitro (in glass, or outside the living organism) to examine specimens. The Thermage ThermaCool System is clearly an in vivo device, used directly on the patient.
N/A
Intended Use / Indications for Use
The Thermage ThermaCool System is indicated for use in:
- The Thermage ThermaCool System is indicated for use in . and General Surgical procedures for Dermatologic electrocoagulation and hemostasis.
- Non-invasive treatment of periorbital wrinkles and rhytids. .
- Non-invasive treatment of facial wrinkles and rhytids. .
Product codes (comma separated list FDA assigned to the subject device)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
K040135, K033942, K021402, K013639, K013034, K003183, K000944
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
§ 878.4400 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
/2
JAN 1 4 2005
510(k) Safety Summary
Name of Device A.
| Trade Name: | Thermage ThermaCool System Treatment Tip |
|---|---|
| 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 |
B. Predicate Devices
ThermaCool TC System and Accessories:
| Device | Premarket Notification |
|---|---|
| ThermaCool System | K040135, Cleared 6/21/04 |
| ThermaCool System | K033942, Cleared 2/4/04 |
| ThermaCool TC System (Model TC) | K021402, Cleared 11/5/02 |
| ThermaCool TC System (Model TC) | K013639, Cleared 1/29/02 |
| Thermage ThermaCool IIA System | K013034, Cleared 10/4/01 |
| Thermage ThermaCool II System | K003183, Cleared 12/8/00 |
| Thermage ThermaCool System | K000944, Cleared 7/19/00 |
C. Device Description
The Thermage ThermaCool System consists of the following components:
- ThermaCool System ●
- Handpiece Assembly (consisting of Handpiece and Treatment Tip) .
1
$$
\xi \circ \xi \circ \xi \circ \xi \circ \xi
$$
- Accessories: Coolant Canister, Coupling Fluid, Return Pad and Skin . Marking Paper
- Accessory cables and tubing .
- Optional footswitch component .
D. Indicated Use
The Thermage ThermaCool System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis. Non-invasive treatment of periorbital wrinkles and rhytids. Non-invasive treatment of facial wrinkles and rhytids.
E. Technical characteristics
The technological characteristics of the modified Thermage ThermaCool System Treatment Tip is substantially equivalent to those of the currently 510(k) cleared Thermage ThermaCool TC System Treatment Tips.
F. Summary
By virtue of design, principle of operation, materials and intended use, the Thermage ThermaCool System Treatment Tip is substantially equivalent to devices currently cleared for marketing in the United States.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
JAN 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Pamela M. Buckman, RN, MS Vice President of Regulatory/Clinical Affairs Thermage, Inc. 25881 Industrial Boulevard Hayward, California 94545
Re: K043402
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: December 9, 2004 Received: December 10, 2004
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 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.
3
Page 2 - Ms. Pamela M. Buckman, RN, MS
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
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
510(k) NUMBER (IF KNOWN): K043402
Thermage ThermaCool System DEVICE NAME: INDICATIONS FOR USE:
The Thermage ThermaCool System is indicated for use in:
- The Thermage ThermaCool System is indicated for use in . and General Surgical procedures for Dermatologic electrocoagulation and hemostasis.
- Non-invasive treatment of periorbital wrinkles and rhytids. .
- 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) |
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices510(k) Number_________________________________________________________________________________________________________________________________________________________________