(115 days)
The CoolTouch Varia Laser System and accessories are indicated for use in Dermatological applications for the treatment of fine lines and wrinkles.
The CoolTouch, Inc. CoolTouch "Varia" Nd:YAG Surgical Laser is a laser producing emissions at 1064nm. 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.
This document, a 510(k) Summary of Safety and Effectiveness for the CoolTouch "Varia" laser system, primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical studies against acceptance criteria in the manner typically seen for novel diagnostic or AI-driven devices.
Therefore, many of the requested sections (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC study details, ground truth types) are not applicable or not present in the provided text.
Based on the available text, here is the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not list specific clinical acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, or a reduction percentage in wrinkles) that the device was tested against. Instead, it states compliance with regulatory standards and claims substantial equivalence to a predicate device for its intended use.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative clinical performance metrics. The primary "acceptance" is demonstrating substantial equivalence to a legally marketed predicate device. | "The CoolTouch Varia Laser System and accessories are indicated for use in Dermatological applications for the treatment of fine lines and wrinkles." The document asserts that the device is "substantially equivalent to the cited legally marketed predicate device for the indications requested." |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. The document does not describe a clinical study with a "test set" in the context of evaluating performance against specific metrics. The claim is based on substantial equivalence, which typically involves demonstrating similar technological characteristics and intended use to an already approved device, rather than new clinical outcome data against set statistical criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. As no specific clinical performance study with a test set generating a ground truth is described, this information is not present.
4. Adjudication method for the test set
Not applicable/Not provided. No clinical performance study with adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable/Not provided. This device is a laser system for dermatological applications, not an AI-driven diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable/Not provided. This is a hardware laser system, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. No ground truth in the context of clinical performance evaluation is described. The "ground truth" for the submission is the regulatory acceptance of the predicate device for its specified indications.
8. The sample size for the training set
Not applicable/Not provided. This is a laser hardware system, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable/Not provided. As this is not an AI/ML device, the concept of a training set and its ground truth is not relevant.
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Summary of Safety and Effectiveness
KO609bb
This 510(k) Summary of Safety and Effectiveness for the CoolTouch "Varia' laser system 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: | CoolTouch, Inc. | |
|---|---|---|
| Address: | 9085 Foothills Blvd.Roseville, CA 95747 - | JUL 3 1 2006 |
| Company Contact: | Donald V. JohnsonVice-President of Operations | |
| Telephone: | (916) 677-1912(916) 677-1901 (FAX) | |
| Date SummaryPrepared: | March 31, 2006 | |
| Device Name: | CoolTouch, Inc. Model "Varia"Nd:YAG Surgical Laser System | |
| Common Name: | Laser Instrument, Surgical Laser System and Accessories | |
| Classification Name: | Instrument, Surgical, Powered Laser21 CFR § 878.4810Product Code: GEX | |
| Predicate Device: | "Lyra" Long Pulse Nd: YAG Laser, Laserscope, San Jose, CA | |
| Device Description: | The CoolTouch, Inc. CoolTouch "Varia" Nd:YAG Surgical Laser is alaser producing emissions at 1064nm. The lasers consist of severalinterconnected sections: the cabinet , which houses the power supply,cooling system, microcontroller, and the laser head, the fiber optics, andthe handpiece . The systems provide safety features that are designedto protect the user and patient from high voltages and laser emissions. |
Intended Use/Indications:
The CoolTouch Varia Laser System and accessories are indicated for use in Dermatological applications for the treatment of fine lines and wrinkles.
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Performance Standards:
The CoolTouch "Varia" laser system complies with the appropriate sections of 21 CFR §1010 and 21 CFR § 1040.
Substantial Equivalence
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Statement:
Based on the information in the premarket notification, the CoolTouch, Inc. believes that the "Varia" Nd:YAG laser system is substantially equivalent to the cited legally marketed predicate device for the indications requested.
April 6, 2006 ·
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 1 2006
CoolTouch, Inc. % Mr. Donald V. Johnson Vice President of Operations 9085 Foothills Boulevard Roseville, California 95747
Re: K060966
Trade/Device Name: CoolTouch Varia Nd: YAG Laser System 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 29, 2006 Received: June 30. 2006
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 Mav 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
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Page 2 - Mr. Donald V. Johnson
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. 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 (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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Helene Semenius
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(K) Number (if known): _ K 0 6 09 b b
Device Name: CoolTouch Varia Nd:YAG Laser System
Indications for Use Statement:
The CoolTouch Varia Laser System and accessories are indicated for use in Dermatological applications for the treatment of fine lines and wrinkles.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Eyatuation (ODE)
Hubert Turner
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
OR Over-the-Counter Use
510(k) Number K666966
Prescription Use (Per 21 CFR 801.109)
§ 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.