(10 days)
Not Found
Not Found
No
The summary describes a laser system for surgical and cosmetic procedures and does not mention any AI or ML components or functionalities.
Yes
The device is specified for various medical treatments, including incision, excision, ablation, vaporization with hemostasis of soft tissue, treatment of fine lines, wrinkles, acne, acne scars, reflux of saphenous veins, and laser-assisted lipolysis, which are all therapeutic indications.
No
The device is a surgical laser indicated for therapeutic procedures like incision, excision, ablation, vaporization, and laser-assisted lipolysis, rather than for diagnosing conditions.
No
The device description explicitly states it is a "Laser System" consisting of a cabinet, fiber optics, and a handpiece or JouleTracker, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to surgical and dermatological procedures performed directly on the patient's body. These include incision, excision, ablation, vaporization, treatment of wrinkles, acne, varicose veins, and laser-assisted lipolysis.
- Device Description: The description details a laser system that emits light at 1320nm and is used with fiber optics and a handpiece. This is consistent with a device used for direct treatment of tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to analyze samples taken from the body to provide diagnostic information. This device is designed to directly interact with and treat the patient's tissues.
N/A
Intended Use / Indications for Use
The CoolTouch Model LC225/CoolTouch CoolLipo 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;
d) for treatment of reflux of the great and small saphenous veins associated with varicose veins and varicosities, and;
e) for laser-assisted lipolysis.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The LC225/CoolLipo 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
soft tissue, back, great and small saphenous veins
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.
CoolTouch LC215/CoolTouch CoolLipo Nd:YAG Laser System
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.
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JUN 2 0 2008
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Premarket Notification 510(k) Summary CoolTouch LC225/CoolTouch CoolLipo Nd: YAG Laser System
This 510(K) Summary of safety and effectiveness for the CoolTouch LC225/CoolTouch CoolLipo 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: | June 9, 2008 | |
| Device Trade Name: | CoolTouch LC225/CoolTouch CoolLipo Nd:YAG Surgical | |
| Laser | ||
| Common Name: | Nd:YAG Pulsed Surgical Laser | |
| Classification Name: | Instrument, Surgical Powered, Laser 79-GEX | |
| Legally Marketed Predicate | ||
| Device: | CoolTouch LC215/CoolTouch CoolLipo | |
| Nd:YAG Laser System | ||
| Description of the CoolTouch | ||
| LC225/CoolLipo Nd:YAG | ||
| Surgical Laser: | The LC225/CoolLipo 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 | ||
| LC225/CoolLipo 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. For laser-assisted lipolysis. | ||
| Performance Data: | None | |
| Conclusion: | Based on the evaluation of the risks and hazards and | |
| including various testing of the modifications, the | ||
| CoolTouch LC225/CoolLipo Nd:YAG Surgical Laser | ||
| System is substantially equivalent to the predicate device, | ||
| the LC215. |
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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 or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 0 2008
New Star Lasers, Inc. % Ms. Natalie R. Vollrath Quality Assurance/Regulatory Affairs Manager 9085 Foothills Boulevard Roseville, California 95747
Re: K081628 Trade/Device Name: CoolTouch LC225/CoolTouch CoolLipo 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: June 9, 2008 Received: June 10, 2008
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
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Page 2 - Ms. Natalie R. Vollrath
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 H. Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number | Pending | |
|---|---|---|
| Device Name | CoolTouch LC225/CoolTouch CoolLipo | |
| Indications for | ||
| Use | The CoolTouch Model LC225/CoolTouch CoolLipo 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; | ||
| d) for treatment of reflux of the great and small saphenous | ||
| veins associated with varicose veins and varicosities, and; | ||
| e) for laser-assisted lipolysis. | ||
| Prescription Use | ||
| (Part 21 CFR 801 Subpart D) | AND/OR | Over-the-Counter Use |
| (21 CFR 801 Subpart C) | ||
| X | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED |
Nulled Qdl for mxn
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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081628 510(k) Number_ Confidential
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