(90 days)
Not Found
No
The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and the device description focuses on standard laser technology components.
Yes
The device is indicated for the "treatment of periorbital and perioral wrinkles," which directly implies a therapeutic use.
No
The device is indicated for the "treatment of periorbital and perioral wrinkles," which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it consists of hardware components: a cabinet housing power supply, cooling system, microcontroller, and laser, along with fiber optics and a handpiece. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of periorbital and perioral wrinkles." This is a therapeutic application performed directly on the patient's body.
- Device Description: The device is a laser system that emits light at 1320 nm. This is a physical treatment modality.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health status. This device is a therapeutic device used for a cosmetic/medical treatment.
N/A
Intended Use / Indications for Use
The CoolTouch Nd:YAG Laser Systems are indicated for the treatment of periorbital and perioral wrinkles.
Product codes
GEX
Device Description
The CoolTouch Nd:YAG Laser Systems are ND:YAG lasers producing laser emission at 1320 nm. The lasers consist of three interconnected sections: The cabinet, which houses the power supply, cooling system, microcontroller and the laser, the fiber optics, and the handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital and perioral
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
Clinical trials produced results that indicate that that CoolTouch Nd:YAG Laser System is effective in the treatment of periorbital and perioral wrinkles.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
| MAR 7 2002 | CoolTouch Corporation
CoolTouch Nd:YAG Laser System
510(k) Premarket Notification |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) SUMMARY | |
| Submitter: | CoolTouch Corporation |
| Address: | 9085 Foothills Boulevard
Roseville, CA 95747 |
| Contact Person: | Donald V. Johnson
Director of Regulatory and Quality Affairs |
| Telephone: | (916) 677-1900 |
| Facsimile: | (916) 677-1901 |
| Date Prepared: | December 6, 2001 |
| Device Trade Name: | CoolTouch Nd:YAG Laser System
CoolTouch-II Nd:YAG Laser System |
| Common Name: | Nd: YAG Pulsed Surgical Laser |
| Classification Name: | Laser Surgical Instrument.
21 C.F.R. § 878.4810 |
| Legally Marketed Predicate Device: | New Star Lasers, Inc. Model 130 Nd:YAG Surgical
Laser System (K962791). |
| Description of the CoolTouch
Nd:YAG Laser Systems: | The CoolTouch Nd:YAG Laser Systems are ND:YAG
lasers producing laser emission at 1320 nm. The lasers
consist of three interconnected sections: The cabinet,
which houses the power supply, cooling system,
microcontroller and the laser, the fiber optics, and the
handpiece. |
| Intended use of CoolTouch
Nd:YAG Laser Systems: | The CoolTouch Nd:YAG Laser Systems are indicated
for the treatment of periorbital and perioral wrinkles. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | Clinical trials produced results that indicate that that
CoolTouch Nd:YAG Laser System is effective in the
treatment of periorbital and perioral wrinkles. |
| Conclusion: | The CoolTouch Nd:YAG Laser Systems are indicated
for the treatment of periorbital and perioral wrinkles. |
| Additional Information: | None requested at this time |
:
1
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 stylized eagle with three tail feathers, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 7 2002
Mr. Donald V. Johnson Director of Regulatory and Quality Affairs CoolTouch Corporation 9085 Foothills Boulevard Roseville, CA 95747
Re: K014035
Trade/Device Name: Cooltouch Nd: YAG Laser System CoolTouch-II Nd:YAG Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 6, 2001 Received: December 7, 2001
Dear Mr. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becaren on the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass suated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered proc to may 20, 1978, are cance with the provisions of the Federal Food, Drug, de neces that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I va may, therefere, mains of the Act include requirements for annual registration, listing of general controll provision 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 olassified (600 wor of ols. Existing major regulations affecting your device can may be subject to such additions, 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 r lease or admissed a determination that your device complies with other requirements of the Act that I Dr Has made a statutes and regulations administered by other Federal agencies. You must of any I oderal bather act's requirements, including, but not limited to: registration and listing (21 compry with an the riev 61 CFR Part 801); good manufacturing practice requirements as set Of It Fat 607), accems (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by sichine (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 – Mr. Donald V. Johnson
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" (21CFR 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
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
3
INDICATION FOR USE STATEMENT
K 014035 510(k) Number: __
Device Name: CoolTouch Corporation "CoolTouch"and "CoolTouch-II" Nd:YAG Laser Systems
Indications for Use:
The CoolTouch Nd:YAG Laser Systems are indicated for the treatment of periorbital and perioral wrinkles.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ V (per 21 CFR 801.109)
OR
Over-the-Counter Use_
Miriam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number K6/4035