(17 days)
No
The document does not mention AI, ML, or related terms, nor does it describe features or processes typically associated with these technologies.
Yes
The device is indicated for non-invasive treatment of periorbital and facial wrinkles and rhytids, which are therapeutic applications.
No
The provided text describes the device's indications for treatment, specifically "electro coagulation and hemostasis" and "non-invasive treatment of periorbital wrinkles and rhytids" and "non-invasive treatment of facial wrinkles and rhytids." It does not mention any diagnostic functions or the identification of diseases or conditions.
No
The device description clearly lists multiple hardware components including a system, handpiece assembly, accessories, cables, tubing, and an optional footswitch. This indicates it is a hardware-based medical device, 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 states the device is 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 in vivo procedures, meaning they are performed on a living organism (the patient).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The Thermage system does not perform such tests.
- Device Description: The components listed are consistent with a device used for applying energy to tissue, not for analyzing biological samples.
Therefore, the Thermage ThermaCool System is a therapeutic device used for surgical and cosmetic 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 electro coagulation and hemostasis,
- Non-invasive treatment 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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510(k) Safety Summary 14.0
OCT 2 0 2005
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 Skin Marking Paper that is the subject of this 510(k) is:
| Accessorv | Predicate | Premarket Notification |
|---|---|---|
| Skin Marking Paper ThermaCool Skin Marking Paper | ||
| Acres and of a free shoulded in of Chind Chief Child Child Child Child Child Child Child Children Mill 141 Me 11807 Million Comments | K032088, Cleared 8/01/03 |
C. 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 .
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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 treatment of periorbital wrinkles and rhytids. Non-invasive treatment of facial wrinkles and rhytids.
Technical characteristics E.
The technological characteristics of the Thermage ThermaCool Skin Marking Paper are substantially equivalent to those of the predicate device.
F. Summary
By virtue of design, principle of operation, materials and intended use, the Thermage ThermaCool Skin Marking Paper is substantially equivalent to devices currently cleared for marketing in the United States.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circle around the eagle.
OCT 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pamela M. Buckman, RN, MS Vice President of Regulatory/Clinical Affairs Thermage, Inc. 25881 Industrial Boulevard Hayward, California 94545-2991
Re: K052778
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: September 30, 2005 Received: October 3, 2005
Dear Ms. Buckman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for abounded in 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). and cooming the efect 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 adultcration.
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 mary of 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 HDA has made a determination that your device complics 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.
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Page 2- Pamela M. Buckman, RN, MS
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin maining of substantial equivalence of your device to a legally prematication: The PDF intentigation 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 IT you desire specific at no 10-10-1 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 other general 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/industry/support/index.html
Sincerely yours.
Barbara Buchner
for
Mark N. Melkerson Acting Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Not Known K052778 510(k) NUMBER (IF KNOWN):
Thermage ThermaCool™ System DEVICE NAME:
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 .
| Prescription Use | X | OR | Over-The-Counter-Use |
|---|---|---|---|
| ------------------ | ---------- | ---- | ---------------------- |
(Per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation (ODE)
[Signature]
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
Thermage ThermaCool Skin Marking Paper 510(k)
| 510(k) Number | K052778 |
|---|---|
| --------------- | --------- |
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