(90 days)
The CoolTouch®, CoolTouch® II, and CoolTouch® CT3 ND:YAG Laser Systems are indicated for the treatment of mild to moderate inflammatory acne vulgaris.
The CoolTouch® Nd: YAG Laser Systems are ND: YAG lasers producing laser emission at 1320nm. The lasers consist of three interconnected section: a) The cabinet, which houses the power supply, cooling system , microcontroler and the laser, b) the fiber optics and c) the handpiece.
The provided text is a 510(k) premarket notification for three CoolTouch® Nd:YAG Laser Systems. It establishes substantial equivalence to a predicate device for the treatment of mild to moderate inflammatory acne vulgaris.
However, the document explicitly states "Performance Data: None" for the CoolTouch® Nd:YAG Laser Systems. Therefore, there is no information in this document to populate most of the requested fields regarding acceptance criteria and study details.
Based only on the provided text, here's what can be answered:
1. Table of Acceptance Criteria and Reported Device Performance:
No acceptance criteria or reported device performance for the CoolTouch® Nd:YAG Laser Systems are provided in this document. The submission states "Performance Data: None".
2. Sample size used for the test set and the data provenance:
Not applicable. No performance study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No performance study data is presented.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No performance study data is presented.
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. This device is a laser system, not an AI-assisted diagnostic tool. No MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No performance study data is presented.
8. The sample size for the training set:
Not applicable. No training set is mentioned as this is a laser device, not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable. No training set is mentioned.
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Section 4
K 040131
:
| Applicant: | New Star Lasers, Inc. |
|---|---|
| Address: | 9085 Foothills BoulevardRoseville, CA 95747 |
| Contact Person: | Donald V. Johnson |
| Telephone / Fax / Email | 916-677-1912 - Phone916-677-1901 - Fax |
| Preparation Date: | January 14, 2004 |
| Device Trade Name: | CoolTouch® Nd:YAG Laser SystemCoolTouch® II Nd:YAG Laser SystemCoolTouch® CT3 Nd:YAG Laser System |
| Common Name: | Nd:YAG Pulsed Surgical Laser |
| Classification Name: | Instrument, Surgical, Powered, laser79-GEX, 21 CFR 878-4810 |
| Legally Marketed Predicate Device: | Candela Smoothbeam™ Laser SystemK030834 Treatment of mild to moderate inflammatory acnevulgaris. |
| Description of the CoolTouch® Nd: Y AGLaser Systems | The CoolTouch® Nd: YAG Laser Systems are ND: YAGlasers producing laser emission at 1320nm. The lasersconsist of three interconnected section: a) The cabinet, whichhouses the power supply, cooling system , microcontrolerand the laser, b) the fiber optics and c) the handpiece. |
| Intended use of the CoolTouch® Nd:YAGLaser Systems | The CooTouch® Nd:YAG Laser System are indicated forthe treatment of mild to moderate inflammatory acnevulgaris. |
| Performance Data: | None |
| Conclusion: | The CoolTouch® Nd:YAG Laser System is substantiallyequivalent to other existing laser systems in commercialdistribution for treatment of mild to moderate inflammatoryacne vulgaris. |
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Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 0 2004
Mr. Donald V. Johnson Vice President, Operations New Star Lasers, Inc. 9085 Foothills Boulevard Roseville, California 95747
Re: K040131
K040131
Trade/Device Name: CoolTouch® Nd:YAG Laser System, CoolTouch® II Nd:YAG Laser System, CoolTouch® CT3 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: January 16, 2004 Received: January 21, 2004
Dear Mr. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regars mannent date of the Medical Device Amendments, or to commerce prior to May 20, 1770, the enasurance with the provisions of the Federal Food, Drug, devices that have tech recatismed in acceraal of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approvise the general controls provisions of the Act. The r ou may, merciole, manel alle act include requirements for annual registration, listing of general controls provisions of the tice, 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 II your device is classified (see above) into existing major regulations affecting your device can may be subject to such additional controller 1. Misting the 1. John 898. In addition, FDA may be found in the Code of Feaster regerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial cquivalence determination docs not mean Please be advised that I Dri 3 issuance of a sudevice complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of any I edical statutes and regarations and uding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CrK Fatt 607), labeling (21 CFR Part 820); and If applicable, the electronic form in the quality systems (Scctions 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Donald V. Johnson
This letter will allow you to begin marketing your device as described in your Section 510(k) i his letter will anow you to oegin manieting of substantial equivalence of your device to a legally premarket notheadon: "The PDF mining of castion 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 If you desire specific acritories - 301) 594-4659. Also, please note the regulation entitled, Colliact the Office of Compulation in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Coness 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
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Section 3
INDICATION FOR USE STATEMENT
510(k) Number: Pending < K040131
Device Name: CoolTouch®, CoolTouch® II, and CoolTouch® CT3 ND:YAG Laser Systems
Indications for Use:
II, and CoolTouch® CT3 The CoolTouch®, CoolTouch® ND:YAG Laser Systems are indicated for the treatment of mild to moderate inflammatory acne vulgaris.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE) miriam C
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K640131 510(k) Number_ Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________ OR 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.