(57 days)
Not Found
Not Found
No
The summary describes a laser system with standard components and safety features, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is indicated for the treatment of back acne and atrophic acne scars, which directly addresses a health condition.
No
The device description and intended use indicate it is a therapeutic laser system for treating skin conditions, not for diagnosing them. It does not mention any diagnostic functionalities like image processing or performance metrics related to diagnostic accuracy.
No
The device description explicitly states it consists of hardware components such as a cabinet, power supply, cooling system, microcontroller, laser head, fiber optics, and handpiece, indicating it is a physical medical device, not software-only.
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 back acne and atrophic acne scars. This is a therapeutic application, not a diagnostic one. IVDs are used to diagnose diseases or conditions.
- Device Description: The description details a laser system used for treatment, not for analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic results.
Therefore, the CoolTouch CT3 ND:YAG Laser System is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CoolTouch CT3 ND:YAG Laser System is indicated for treatment of back acne and treatment of atrophic acne scars.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The CoolTouch Incorporated CoolTouch CT3 Nd:YAG Surgical Lasers are lasers producing emissions at 1320nm. The lasers consist of several interconnected sections: the cabinet, which houses the power supply, cooling system, microcontroller, and the laser head, the fiber optics, and the handpiece. The systems provide safety features that are designed to protect the user and patient from high voltages and laser emissions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
back
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.
CoolTouch Incorporated "CoolTouch" and "CoolTouch II" Nd:YAG Laser Systems
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
§ 878.4810 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
'AUG 21 2003
Summary of Safety and Effectiveness
KO31954
This 510(k) Summary of Safety and Effectiveness for the CoolTouch CT3 laser systems is submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92 and 21 CFR § 807.93 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) Summary.
| Applicant: | New Star Lasers, Inc. d.b.a. CoolTouch Incorporated |
|---|---|
| Address: | 9085 Foothills Blvd. |
| Roseville, CA 95747 | |
| Company Contact: | Donald V. Johnson |
| Vice-President, Operations | |
| Telephone: | (916) 677-1912 |
| (916) 677-1901 (FAX) | |
| Date Summary | |
| Prepared: | June 24, 2003 |
| Device Name: | CoolTouch Incorporated Model CT3 |
| Laser Systems | |
| Common Name: | Laser Instrument, Surgical Laser System and Accessories |
| Classification Name: | Instrument, Surgical, Powered Laser |
| 21 CFR § 878.4810 | |
| Product Code: GEX | |
| Predicate Device: | CoolTouch Incorporated "CoolTouch" and "CoolTouch II" Nd:YAG |
| Laser Systems | |
| Device Description: | The CoolTouch Incorporated CoolTouch CT3 Nd:YAG Surgical Lasers |
| are lasers producing emissions at 1320nm. The lasers consist of several | |
| interconnected sections: the cabinet, which houses the power supply, | |
| cooling system, microcontroller, and the laser head, the fiber optics, and | |
| the handpiece. The systems provide safety features that are designed to | |
| protect the user and patient from high voltages and laser emissions. |
Intended Use/Indications:
The CoolTouch CT3 ND:YAG Laser System is indicated for treatment of back acne and treatment of atrophic acne scars
1
K031954 2 of 2
510(k) Premarket Notification CoolTouch Incorporated Model CT3 Laser Systems June 24, 2003
Performance
Standards:
The CoolTouch CT3 laser systems comply with the appropriate sections of 21 CFR §1010 and 21 CFR § 1040.
Substantial Equivalence Statement:
Based on the information in the premarket notification, CoolTouch Incorporated believes that the CoolTouch CT3 Nd:YAG laser systems are substantially equivalent to the cited legally marketed predicate device for the indications requested.
June 24, 2003
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the emblem. The emblem is composed of three curved lines that form the shape of a person.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 21 2003
Mr. Donald V. Johnson Vice President, Operations CoolTouch Incorporated 9085 Foothills Boulevard Roseville. California 95747
Re: K031954
Trade/Device Name: CoolTouch Incorporated Model CT3 Laser Systems Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 24, 2003 Received: July 1, 2003
Dear Mr. Johnson:
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. Iisting 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 (OS) 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 - 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), please contact the Office of Compliance at (301) 594-4659. 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,
Mark N Melkerson
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
INDICATIONS FOR USE STATEMENT
510(K) Number (if known): K031954
Device Name: CoolTouch Incorporated Model CT3
Indications for Use Statement:
The CoolTouch CT3 Laser System is indicated for:
- treatment of back acne 1.
-
- treatment of atrophic acne scars.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark N. Milbern
(Division Sign-Off) Division of General, Restorative and Neurological Devices
ೆ (k) Number -