(115 days)
"Lyra" Long Pulse Nd: YAG Laser
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 typically associated with AI/ML devices.
Yes
The device is indicated for "treatment of fine lines and wrinkles," which is a therapeutic application.
No
Explanation: The device is indicated for treatment (fine lines and wrinkles) rather than diagnosis. It directly performs an action (laser emission) on the patient.
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.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Dermatological applications for the treatment of fine lines and wrinkles." This is a therapeutic application performed directly on the patient's body.
- Device Description: The device is a surgical laser that emits light at 1064nm and is applied externally via a handpiece. This is a physical intervention, not a test performed on a sample taken from the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
The CoolTouch Varia Laser System is a therapeutic device used for a dermatological procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The CoolTouch Varia Laser System and accessories are indicated for use in Dermatological applications for the treatment of fine lines and wrinkles.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
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.
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 (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.
"Lyra" Long Pulse Nd: YAG Laser, Laserscope, San Jose, CA
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
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. Johnson | |
| Vice-President of Operations | ||
| Telephone: | (916) 677-1912 | |
| (916) 677-1901 (FAX) | ||
| Date Summary | ||
| Prepared: | 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 Laser | |
| 21 CFR § 878.4810 | ||
| Product 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 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. |
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.
1
Performance Standards:
The CoolTouch "Varia" laser system complies with the appropriate sections of 21 CFR §1010 and 21 CFR § 1040.
Substantial Equivalence
.
.
.
:
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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Image /page/2/Picture/1 description: The image shows a logo with a circular border containing text, surrounding a stylized symbol. The symbol consists of three curved lines that resemble a bird in flight or abstract human profiles. The text around the border is not clearly legible due to the image quality, but it appears to be part of the organization's name or motto. The logo is presented in black and white.
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)