(11 days)
Not Found
Not Found
No
The document describes a radiofrequency (RF) system for dermatological procedures and makes no mention of AI or ML technology.
Yes
The device is indicated for "non-invasive treatment of wrinkles and rhytids," which is a therapeutic purpose, and it performs "electro coagulation and hemostasis" in surgical procedures, also therapeutic.
No
Explanation: The "Intended Use / Indications for Use" section describes the device's functions as "electro coagulation and hemostasis" and "non-invasive treatment of wrinkles and rhytids." These are therapeutic or treatment-oriented functions, not diagnostic ones. There is no mention of identifying, detecting, or measuring a disease or condition.
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. 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 uses listed are "Dermatologic and general surgical procedures for electro coagulation and hemostasis" and "Non-invasive treatment of wrinkles and rhytids." These are procedures performed on the patient's body, not on samples taken from the body (like blood, urine, or tissue) in a laboratory setting.
- Device Description: The components described (RF Generator, Cooling Module, Handpiece, etc.) are consistent with a device used for external application to the skin and underlying tissues. There is no mention of components typically found in IVD devices, such as reagents, analyzers, or sample handling systems.
- Lack of IVD-related information: The document does not mention any of the elements that would be expected for an IVD, such as analysis of biological samples, diagnostic purposes, or performance metrics related to diagnostic accuracy.
Therefore, the Thermage ThermaCool System is a therapeutic and surgical device, 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 wrinkles and rhytids
Product codes
GEI
Device Description
This special 510(k) application covers a system identical to the earlier devices and clearances.
The Thermage ThermaCool System consists of the following components:
*RF Generator
*Cooling Module
*Cryogen Canister
*Handpiece Assembly (consisting of Handpicce and Treatment Tip)
- Accessory cables and tubing
*Optional footswitch component - Accessories: coupling fluid, return pad and skin marking paper
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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
DEC 1 3 2005
| 510(k) Summary Information | THERMAGE, INC. |
|---|---|
| Premarket Notification, Section 510(k) | NOVEMBER 28, 2005 |
Pursuant to the Safe Medical Devices Act of 1990, 21 CFR 807.92
Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority:
Thermage ThermaCool System Trade Name:
Common
Electrosurgical cutting and coagulation device Name(s):
Classification
Electrosurgical cutting and coagulation device Name(s):
Establishment Name & Registration Number:
THERMAGE, INC. Name: Number:
Classification(s):
:
$ 878.4400 Electrosurgical cutting and coagulation device and accessories.
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. Classification. Class II.
Class II for all requested indications Device Class: Classification Panel: General and Plastic Surgery Product Code(s): GEI
Equivalent Predicate Device:
The Thermage ThermaCool System is substantially identical to the following device system:
Device Description:
This special 510(k) application covers a system identical to the earlier devices and clearances.
The Thermage ThermaCool System consists of the following components:
*RF Generator
*Cooling Module
*Cryogen Canister
*Handpiece Assembly (consisting of Handpicce and Treatment Tip)
- Accessory cables and tubing
*Optional footswitch component
- Accessories: coupling fluid, return pad and skin marking paper
Indications for Use:
The Thermage ThermaCool System is indicated for use in Dermatologic and General Surgical I in Thermige Thermicone bysten 'no hemostasis. Non-invasive treatment of wrinkles & rhytids.
Applicant Name & Address:
Thermage, Inc. 25881 Industrial Blvd. Hayward, CA 94545-2991 510 782 2286 voice 510 782 2287 fax
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 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 text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing three abstract shapes, possibly representing support or care.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2005
Ms. Pamela M. Buckman, RN, MS V. P. Clinical & Regulatory Affairs Thermage, Inc. 25881 Industrial Blvd. Hayward, California 94545-2991
Re: K053365
K055565
Trade/Device Name: Thermage ThermaCool System Regulation Number: 21 CFR 878.4400 Regulation Number: 21 CFN 878.4400
Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 30, 2005 Received: December 2, 2005
Dear Ms. Buckman:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IV(E) prematice is substantially equivalent (for the indications
referenced above and have determined the device is substantially interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to regary manced to concel Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drug. commerce prior to May 28, 1976, the enactinent with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval assessment opprovisions of the Act . T and Cosmetic Act (Act) that do not require approved controls provisions of the Act. The Act. The
You may, therefore, market the device, subject to the general registrat You may, therefore, market the device, subject to annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act mende requirement.
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 If your device is classified (see above) mio entire cass in engelations affecting your device can
may be subject to such additional controls. Existing major regulations alle may be subject to such additions. Title 21, Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Code of Federal Regalations, concerning 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 substance only other requirements of the Act
that FDA has made a determination that your device Edgeral of our must that FDA has made a delectimation administered by other Federal agencies. You must or any Federal statutes and regulations administered to: registration and listing (21 largestration and listing (21 l comply with all the Act s requirements, incriating practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); end if emplicable, the electronic CFR Part 807); labeling (21 CFR Part 800); god analysis (20); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat); 21 CFR 1000-1050 forth in the quality systems (Q5) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
2
Page 2 - Ms. Buckman
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegill maketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial end thus, permits vou premarket notification. The FDA inding of substantial required in 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
rstilled If you desire specific advice for your device of your accesse note the regulation entitled, the more abtain contact the Office of Complaned at (216) 276-6101" (21CFR Part 807.97). You may obtain "Misbranding by reletence to premantel routhead.com the Act from the Division of Small other general Information on your responsion Assistance at its toll-free number (800) 638-2041 or and Manufacturers, International and Collsuner Flosbuller Flosbules and Consult industry/support/index.html
Sincerely yours,
barbay Buehup
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
KOS3361 Not Known 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 wrinkles and rhytids L
| And American
Prescription Use
Second a " . " . " . " | ------------------------------------------------------------------------------- | OP
c
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Over-The-Counter-Use
. | |
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------- | -- |
|---|
(Per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shalane Buehl
Division Sign-Off
Division of General, Restorative and Neurological Devices
Special 510(k)ThermaCool.doc
510(k) Number. K053365
15