(90 days)
Not Found
No
The summary describes a laser system for acne treatment and does not mention any AI or ML components or functionalities.
Yes.
The device is indicated for the treatment of a medical condition (mild to moderate inflammatory acne vulgaris), which signifies a therapeutic purpose.
No
Explanation: The device is indicated for the "treatment" of acne, which means it is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it consists of a cabinet housing hardware components (power supply, cooling system, microcontroller, laser), fiber optics, and a handpiece, indicating it is a hardware device.
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 mild to moderate inflammatory acne vulgaris. IVDs are used for the diagnosis of diseases or conditions.
- Device Description: The device is a laser system that emits light to treat a condition. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information.
This device is a therapeutic device, specifically a laser system used for treatment.
N/A
Intended Use / Indications for Use
The CooTouch® Nd:YAG Laser System are indicated for the treatment of mild to moderate inflammatory acne vulgaris.
Product codes (comma separated list FDA assigned to the subject device)
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: a) The cabinet, which houses the power supply, cooling system , microcontroler and the laser, b) the fiber optics and c) the handpiece.
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)
None
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.
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
Section 4
K 040131
:
| Applicant: | New Star Lasers, Inc. |
|---|---|
| Address: | 9085 Foothills Boulevard |
| Roseville, CA 95747 | |
| Contact Person: | Donald V. Johnson |
| Telephone / Fax / Email | 916-677-1912 - Phone |
| 916-677-1901 - Fax | |
| Preparation Date: | January 14, 2004 |
| Device Trade Name: | CoolTouch® Nd:YAG Laser System |
| CoolTouch® II Nd:YAG Laser System | |
| CoolTouch® CT3 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 |
| K030834 Treatment of mild to moderate inflammatory acne | |
| vulgaris. | |
| Description of the CoolTouch® Nd: Y AG | |
| Laser Systems | 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. | |
| Intended use of the CoolTouch® Nd:YAG | |
| Laser Systems | The CooTouch® Nd:YAG Laser System are indicated for |
| the treatment of mild to moderate inflammatory acne | |
| vulgaris. | |
| Performance Data: | None |
| Conclusion: | The CoolTouch® Nd:YAG Laser System is substantially |
| equivalent to other existing laser systems in commercial | |
| distribution for treatment of mild to moderate inflammatory | |
| acne vulgaris. |
1
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.
2
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
3
Section 3
INDICATION FOR USE STATEMENT
510(k) Number: Pending