(36 days)
Not Found
No
The summary describes a laser system with standard components and does not mention any AI or ML capabilities.
Yes.
The device is used for incision, excision, ablation, and vaporization of soft tissue, as well as the treatment of fine lines and wrinkles, which are all therapeutic interventions.
No
The device is described as a surgical laser system used for incision, excision, ablation, and vaporization of soft tissue, as well as for treating fine lines and wrinkles. Its functions are therapeutic/surgical rather than diagnostic.
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-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for surgical procedures on soft tissue in dermatology (incision, excision, ablation, vaporization) and for treating fine lines and wrinkles. These are direct treatments performed on the patient's body.
- Device Description: The device is a surgical laser system that emits laser energy. This is a therapeutic device, not a device used to examine specimens from the body to diagnose conditions.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to directly interact with and modify tissue.
N/A
Intended Use / Indications for Use
For use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue. For use in the treatment of fine lines and wrinkles.
Product codes
GEX
Device Description
The New Star CoolTouch® Nd:YAG Surgical Laser Systems are ND:YAG lasers producing laser emission at 1320 nm. The lasers consists of three interconnected sections: The cabinet which houses the power supply, the cooling system, the 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
soft tissue
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)
New Star Lasers, Inc. Model NS-130 (CoolTouch®) and Model CoolTouch® II Nd:YAG Laser Systems
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
031184
Premarket Notification 510(k) Summary (As Required by 21 CFR 807.93
This 510(K) Summary of safety and effectiveness for the New Star Model CoolTouch® 3 Nd:YAG Surgical Laser system is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| 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 | |
| djohnson@newstarlasers.com - Email | |
| Preparation Date: | April 14, 2003 |
| Device Trade Name: | New Star Nd:YAG Surgical Laser Model CoolTouch® 3 |
| Common Name: | Nd: YAG Pulsed Surgical Laser |
| Classification Name: | Instrument, Surgical, Powered, laser |
| 79-GEX | |
| 21 CFR 878-4810 | |
| Legally Marketed Predicate Device: | New Star Lasers, Inc. Model NS-130 (CoolTouch®) and |
| Model CoolTouch® II Nd:YAG Laser Systems | |
| Description of the New Star CoolTouch® | |
| Nd:YAG Laser Systems: | The New Star CoolTouch® Nd:YAG Surgical Laser Systems |
| are ND:YAG lasers producing laser emission at 1320 nm. | |
| The lasers consists of three interconnected sections: The | |
| cabinet which houses the power supply, the cooling system, | |
| the microcontroller and the laser, the fiber optics and the | |
| handpiece. | |
| Intended use of the New Star CoolTouch® | |
| Nd:YAG Laser Systems: | For use in dermatology for incision, excision, ablation and |
| vaporization with hemostasis of soft tissue. For use in the | |
| treatment of fine lines and wrinkles. | |
| Performance Data: | None |
| Conclusion: | The New Star CoolTouch® 3 Nd:YAG Surgical Laser |
| System is substantially equivalent to the predicate devices, | |
| the New Star CoolTouch® and CoolTouch® II Nd:YAG | |
| laser systems. | |
| Additional Information: | None requested at this time |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle head with three lines extending from the back of the head, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 21 2003
Mr. Donald V. Johnson Vice President of Operations New Star Lasers, Inc. 9085 Foothills Boulevard Roseville, California 95747
Re: K031184
Trade/Device Name: New Star Nd: YAG Surgical Laser Model CoolTouch® 3 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: April 14, 2003 Received: April 24, 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. 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 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 yours,
for Mark 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
510(k) Number
Not yet assigned
CoolTouch® 3 Device Name
For use in dermatology for incision, excision, ablation and Indications for vaporization with hemostasis of soft tissue. For use in the Use 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 Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
Mark N. Mulkerson
(Division Sign-Off) Division of General, Restorative and Neurologi al Devices
510(k) Numbe
New Star Lasers, Inc April 14, 2003
Special 510(k) Submission CoolTouch 3 Nd:YAG Laser System