(35 days)
None
Not Found
No
The summary describes a laser system for surgical and dermatological applications and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for various medical treatments, including soft tissue incision/excision, treatment of fine lines/wrinkles, back acne/acne scars, and venous reflux, which are all therapeutic applications.
No
The device is described as a surgical laser used for various treatments like incision, excision, ablation, and vaporization of soft tissue, as well as treatment for wrinkles, acne scars, and varicose veins. These are all therapeutic applications, not diagnostic ones.
No
The device description explicitly states it is a "Laser System" consisting of a cabinet, fiber optics, and a handpiece, which are all 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 examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- CoolTouch LC215 Function: The description clearly states the CoolTouch LC215 is a surgical laser used for procedures performed on the body (in vivo). It's used for incision, excision, ablation, vaporization, and treatment of veins and skin conditions.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological specimens, laboratory testing, or diagnostic information derived from samples.
Therefore, based on the provided information, the CoolTouch Model LC215 Nd:YAG Surgical Laser is a therapeutic and surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CoolTouch Model LC215 Nd:YAG Surgical Laser is indicated for the following:
a) for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue;
b) for use in the treatment of fine lines and wrinkles;
c) for treatment of back acne and atrophic acne scars, and;
d) for treatment of reflux of the great and small saphenous veins associated with varietse veins and varicosities.
Product codes
GEX
Device Description
The CoolTouch LC215 Nd: YAG Laser System produces laser emission at 1320nm. The laser 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 or JouleTracker
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
None
Key Metrics
Not Found
Predicate Device(s)
CoolTouch CT3S Nd:YAG Laser System
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
KD72424
OCT 3 * 2007
Premarket Notification 510(k) Summary CoolTouch LC215 Nd:YAG Laser System
This 510(K) Summary of safety and effectiveness for the CoolTouch LC215 Nd:YAG surgical laser system is submitted in accordance with the requirements of 21CFR 807.92.
| Applicant: | New Star Lasers, Inc. dba CoolTouch, Inc. |
|---|---|
| Address: | 9085 Foothills Boulevard |
| Roseville, CA 95747 | |
| Contact Person: | Natalie R. Vollrath |
| Telephone: | (916) 677-1900 |
| Fax: | (916) 677-1901 |
| Preparation Date: | August 27, 2007 |
| Device Trade Name: | CoolTouch LC215 Nd: YAG Surgical Laser |
| Common Name: | Nd: YAG Pulsed Surgical Laser |
| Classification Name: | Instrument, Surgical Powered, Laser 79-GEX |
| Legally Marketed Predicate | |
| Device: | CoolTouch CT3S |
| Nd:YAG Laser System | |
| Description of the CoolTouch | |
| LC215 Nd:YAG Surgical Laser: | The LC215 Nd: YAG Laser System produces laser emission |
| at 1320nm. The laser 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 or JouleTracker | |
| Intended use of the CoolTouch | |
| LC215 Nd:YAG Surgical Laser: | 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. For treatment of back | |
| acne and atrophic acne scars. For treatment of reflux of the | |
| great and small saphenous veins associated with varicose | |
| veins and varicosities | |
| Performance Data: | None |
| Conclusion: | Based on the evaluation of the risks and hazards and |
| including various testing of the modifications, the | |
| CoolTouch LC215 Nd:YAG Surgical Laser System is | |
| substantially equivalent to the predicate device, the CT3S |
1
Image /page/1/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. In the center of the circle is a stylized emblem that resembles three abstract human profiles or faces stacked on top of each other, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
New Star Lasers, Inc. dba CoolTouch Inc % Ms. Natalie Vollrath Quality Assurance Manager 9085 Foothills Boulevard Roseville, California 95747
OCT 3 * 2007
Re: K072424
Trade/Device Name: CoolTouch LC215 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: September 18, 2007 Received: September 19, 2007
Dear Ms. Vollrath:
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
2
Page 2 - Ms. Vollrath
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/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director
Division of General, Restorative
and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
| 510(k) Number | Pending |
|---|---|
| --------------- | --------- |
Device Name
CoolTouch LC215
Indications for Use
The CoolTouch Model LC215 Nd:YAG Surgical Laser is indicated for the following:
a) for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue;
b) for use in the treatment of fine lines and wrinkles;
c) for treatment of back acne and atrophic acne scars, and;
d) for treatment of reflux of the great and small saphenous veins associated with varietse veins and varicosities.
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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