(151 days)
Not Found
No
Yes
The device is indicated for non-invasive treatment of periorbital and facial wrinkles and rhytids, which constitutes a therapeutic use.
No
The Thermage ThermaCool System is indicated for treatment (electro coagulation, hemostasis, and non-invasive treatment of wrinkles), not for diagnosis.
No
The device description clearly lists multiple hardware components including an RF Generator, Cooling Module, Cryogen Canister, Handpiece Assembly, cables, tubing, and an optional footswitch. This indicates it is a hardware-based system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "Dermatologic and general surgical procedures for electro coagulation and hemostasis," and "Non-invasive treatment of periorbital wrinkles and rhytids," and "Non-invasive treatment of facial wrinkles and rhytids." These are all therapeutic or surgical procedures performed directly on the patient's body.
- Device Description: The components described (RF Generator, Cooling Module, Handpiece Assembly, etc.) are consistent with a device that delivers energy to the body for treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to be used in vitro (outside the body) to examine specimens and provide information about a person's health status.
The Thermage ThermaCool System is a therapeutic medical device used for cosmetic and surgical procedures.
N/A
Intended Use / Indications for Use
The Thermage ThermaCool System is indicated for use in:
- · Dermatologic and general surgical procedures for electro coagulation 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:
- 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, 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.
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
| JUN 2 1 2004 | K040135 1/3 |
|---|---|
| -------------- | ------------- |
13.0 510(k) Safety Summary
A. Name of Device
| 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, Regulatory/Clinical Affairs |
B. Predicate Device
ThermaCool System
| 510 (k) Number | Name of Device | Decision Date |
|---|---|---|
| K021402 | ThermaCool TC | November 5, 2002 |
C. Device Description
The Thermage ThermaCool 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.
D. Indicated Use
The Thermage ThermaCool System is indicated for use in Dermatologic and General Surgical procedures for electro coagulation and hemostasis; noninvasive treatment of periorbital wrinkles and mytids and non-invasive treatment of facial wrinkles and rhytids.
1
040131 2/3
There is a sterilization contract in compliance with 21 CFR 801.150 between Thermage and IBA Griffith. This contract defines the responsibilities of both parties. Sterilization validation will be performed in accordance with EN 550, utilizing the half-cycle method of sterilization validation to verify a sterility assurance level of 10 .
EO Residuals
Acceptable EO residual levels will be in conformance with the requirements of consensus standard ISO 10993-7: Biological Evaluation of Medical Devices Part 7 Ethylene Oxide Sterilization Residuals. The Thermage Treatment Tip is a "limited exposure" device in accordance with ISO 10993-1:1992, subclause 5.2 (limited exposure; devices whose single or multiple use or contact is likely to be up to 24 hours). Allowable limits for limited exposure devices are: 20 mg EO and 12 mg ECH (average daily dose).
Verification that EO and ECH residuals are below allowable limits shall be confirmed as part of the EO cycle and product aeration validation. Manufactured product shall also be routinely monitored for EO and ECH residuals (minimum quarterly).
Skin Marking Paper
Sterilization
The Thermage Skin Marking Paper will be sterilized using 100% ethylene oxide at IBA Griffith in Salt Lake City, Utah. The address is 5725 West Harold Gatty Road, Salt Lake City, Utah 84116. The establishment registration number is 1721676.
There is a sterilization contract in compliance with 21 CFR 801.150 between Thermage and IBA Griffith. This contract defines the responsibilities of both parties. Sterilization validation will be performed in accordance with EN 550, utilizing the half-cycle method of sterilization validation to verify a sterility assurance level of 10 . O
EO Residuals
Acceptable EO residual levels will be in conformance with the requirements of consensus standard ISO 10993-7: Biological Evaluation of Medical Devices Part 7 Ethylene Oxide Sterilization Residuals. The Thermage Skin Marking Paper is a "limited exposure" device in accordance with ISO 10993-1:1992, subclause 5.2 (limited exposure: devices whose single or multiple use or contact is likely to be up to 24 hours). Allowable limits for limited exposure devices are: 20 mg EO and 12 mg ECH (average daily dose).
Verification that EO and ECH residuals are below allowable limits shall be confirmed as part of the EO cycle and product aeration validation. Manufactured product shall also be routinely monitored for EO and ECH residuals (minimum quarterly).
2
040135 3/3
Technical characteristics نا
The technological characteristics and clinical use data of the ThermaCool System for the expanded indication are substantially equivalent to the previously cleared ThermaCool TC System.
ப் Summary
By virtue of design, principle of operation, materials and intended use, the Thermage ThermaCool System is substantially equivalent to devices currently cleared for marketing in the United States.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the seal of the 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 an abstract image of an eagle.
JUN 2 1 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Pamela M. Buckman, RN, MS Vice President, Regulatory/Clinical Affairs Thermage 4058 Point Eden Way Hayward, California 94545-3721
Re: K040135
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: April 30, 2004 Received: May 3, 2004
Dear Ms. Buckman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bector. 9 rQxy press.
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 for use stated in the encrosule) to regally manent date of the Medical Device Ameridae, or to commerce prior to May 20, 1776, the enational with the provisions of the Federal Food. Drug. devices that have been recalismed in assess approval of a premarket approval application (PMA). and Cosment Act (Act) market the device, subject to the general con.rols provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the Fist labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (secure) nits existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations iPA ma may be subject to such additional controller issues of the 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Peachar Succerning 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 I Dri 3 issualites over device complies with other requirements of the Act that FDA has made a delemination administered by other Federal agencies. You must or any Federal statures and regulations daministered of registration and listing (21 letting (21 let comply with an the Act 3 requirements) 110, good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and 1f applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
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) This letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket notification. The PDA miding of substantal equice 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 do not on one and the regulation entitled, the regulation entitled, comaci the Office of Compunation at (301) of the Part 807.97). You may obtain "Misbranding by relerence to premantel notilities. In the Act from the Division of Small other general information on your responsions at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at the consumer attrak Manufacturers, International and Consenter Passes http://www.fda.gov/cdrh/dsmamain.html
Sincerely yours,
Miriam C. Provost
fal 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
5
(IF Not Known NUMBER 510(k) KNOWN):
Thermage ThermaCool System
INDICATIONS FOR USE:
DEVICE NAME:
The Thermage ThermaCool System is indicated for use in:
- · Dermatologic and general surgical procedures for electro coagulation 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 Devices
510(k) Number: K040135
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