(90 days)
Not Found
No
The summary describes a laser system with standard components and does not mention any AI or ML related terms or functionalities.
Yes
The device is indicated for the treatment of medical conditions (back acne, atrophic acne scars), which classifies it as a therapeutic device.
No
The device description and intended use indicate it is a therapeutic device for treating acne and acne scars, not for diagnosing conditions.
No
The device description explicitly states it is a laser system consisting of a cabinet, fiber optics, and a handpiece, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- CoolTouch® ND:YAG Laser System Function: The description clearly states that this is a laser system used for the treatment of back acne and atrophic acne scars. It applies energy to the body for therapeutic purposes.
The intended use and device description are consistent with a therapeutic medical device, not a diagnostic one that analyzes samples.
N/A
Intended Use / Indications for Use
The CoolTouch® ND:YAG Laser System is indicated for:
- treatment of back acne
- treatment of atrophic acne scars
Product codes
GEX
Device Description
The CoolTouch® Nd:YAG Laser Systems are ND:YAG lasers producing laser emission at 1320nm. The lasers consist of three interconnected section: 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
back (for acne treatment); Not specified (for atrophic acne scars)
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)
None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
0 304153
Section 4 510(K) Summary CoolTouch® Nd:YAG Laser System
MAY 1 2 2003
| Applicant: | New Star Lasers, Inc. |
|---|---|
| Address: | 9085 Foothills Boulevard |
| Roseville, CA 95747 | |
| Contact Person: | Donald V. Johnson |
| Telephone / Fax / Email | 916-677-1900 - Phone |
| 916-677-1901 - Fax | |
| Preparation Date: | February 5, 2003 |
| Device Trade Name: | CoolTouch® Nd:YAG Laser System |
| CoolTouch® II Nd:YAG Laser System | |
| Common Name: | Nd:YAG Pulsed Surgical Laser |
| Classification Name: | Instrument, Surgical, Powered, laser |
| 79-GEX, 21 CFR 878-4810 | |
| Legally Marketed Predicate Device: | Candela Smoothbeam™ Laser System |
| K014128 for treatment of back acne | |
| K022884 for treatment of atrophic acne scars | |
| Description of the CoolTouch® Nd:YAG | |
| Laser Systems | The CoolTouch® Nd:YAG Laser Systems are ND:YAG |
| lasers producing laser emission at 1320nm. The lasers | |
| consist of three interconnected section: The cabinet which | |
| houses the power supply, cooling system, microcontroller | |
| and the laser, the fiber optics and the handpiece. | |
| Intended use of the CoolTouch® Nd:YAG | |
| Laser Systems | The CoolTouch® Nd:YAG Laser System are indicated for |
| the treatment of back acne and the treatment of atrophic | |
| acne scars. | |
| Performance Data: | None |
| Conclusion: | The CoolTouch® Nd:YAG Laser System is substantially |
| equivalent to other existing laser systems in commercial | |
| distribution for treatment of back acne and treatment of | |
| atrophic acne scars. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked one behind the other. The profiles are simple and abstract, with flowing lines suggesting hair or movement.
MAY 1 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Donald V. Johnson Vice President, Operations New Star Lasers, Inc. 9085 Foothills Boulevard Roseville, California 95747
Re: K030453 Trade/Device Name: CoolTouch Nd:YAG Laser System CoolTouch II 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: February 11, 2003 Received: February 11, 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. listing 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 (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.
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), 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) you may obtain. 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 vours.
Sincerely yours,
Marki N Millerson
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
Ka30413 Pending 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: CoolTouch® ND:YAG Laser System
Indications for Use:
The CoolTouch® ND:YAG Laser System is indicated for:
-
- treatment of back acne
-
- 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)
Prescription Use and the prescription use is selected.