COOLTOUCH MODELS LC215 AND COOLLIPO

• K Number: K080163
• Device Name: COOLTOUCH MODELS LC215 AND COOLLIPO
• Manufacturer: NEW STAR LASERS, INC.
• Date Cleared: 2008-04-10 ( 78 days)
• Product Code: GEX
• Regulation Number: 878.4810
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K072751 , K072424
• Predicate For: N/A

Intended Use

In addition to previously cleared indications for use, the CoolTouch Model LC215/CoolLipo Nd:YAG Surgical Laser is indicated for laser-assisted lipolysis.

Device Description

The CoolTouch LC215/CoolLipo Surgical Laser System is an Nd:YAG laser producing laser emission at 1320 nm. The laser consists of a cabinet which houses the power supply, the cooling system, microcontroller, laser, foot switch, and the fiber optic for delivery of the laser energy with microcannula setup.

AI/ML Overview

The provided text is a 510(k) summary for the CoolTouch LC215/CoolLipo Nd:YAG Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a study proving its performance against specific criteria.

Therefore, many of the requested details, such as specific acceptance criteria, reported performance against those criteria, sample sizes for test and training sets, expert qualifications, and ground truth establishment, are not available in this document.

Here's what can be extracted and what is explicitly stated as not available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not Available	Not Available
(The document states "Clinical Performance Data: None" and "Nonclinical Performance Data: None")

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable, as no clinical or non-clinical performance data is reported. The document states "Clinical Performance Data: None" and "Nonclinical Perfomance Data: None".
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable, as no clinical or non-clinical performance data is reported.

4. Adjudication method for the test set

• Not applicable, as no clinical or non-clinical performance data is reported.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC comparative effectiveness study was done. This device is a laser surgical system, not an AI-assisted diagnostic or imaging device. The document explicitly states "Clinical Performance Data: None".

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No standalone performance study of an algorithm was done. This document pertains to a physical medical device (laser system), not an algorithm. The document explicitly states "Clinical Performance Data: None".

7. The type of ground truth used

• Not applicable, as no clinical or non-clinical performance data is reported.

8. The sample size for the training set

• Not applicable, as no clinical or non-clinical performance data is reported.

9. How the ground truth for the training set was established

• Not applicable, as no clinical or non-clinical performance data is reported.

Summary from the provided document:

The 510(k) summary indicates that the CoolTouch LC215/CoolLipo Nd:YAG Laser System is deemed "substantially equivalent" to predicate devices based on its principle of operation, wavelength, and essentially the same pulse energy rate. The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None," meaning no new studies were conducted to prove its performance against specific acceptance criteria for this 510(k) submission. The FDA clearance is based on the device's technical specifications aligning with previously cleared devices.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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New Star Lasers, Inc. % Ms. Natalie R. Vollrath Quality Assurance Manager 9085 Foothills Boulevard Roseville, California 95747

APR 1 0 2008

Re: K080163

Trade/Device Name: CoolTouch LC215/CoolLipo 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 22, 2008 Received: January 23, 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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Millman

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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K080163

510(k) Number

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Device Name	CoolTouch LC215/CoolLipo Nd:YAG Laser System
Indications forUse	In addition to previously cleared indications for use, theCoolTouch Model LC215/CoolLipo Nd:YAG Surgical Laseris indicated for laser-assisted lipolysis.

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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Appendix 2 510(k) Summary

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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 LC21/CoolLipoo This JTQ(K) Surgical Laser systems in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(k) summary.

Submitter:	New Star Lasers, Inc. d.b.a. CoolTouch, Inc.
Address:	9085 Foothills BoulevardRoseville, CA 95747
Contact Person:	Natalie VollrathQuality Assurance Manager
Telephone/Fax/Email:	[phone] - Phone[phone] - [e-mail] - Email
Date prepared:	January 22, 2008
Device Trade Name:	CoolTouch LC215/CoolLipo Nd:YAG SurgicalLaser
Common Name:	Nd: YAG Surgical Laser
Classification Name:	Instrument, surgical, powered, laser79-GEX21 CFR §878.4810
Legally Marketed PredicateDevices:	CoolTouch NS160 CoolLipo Nd: YAG lasersystem (K072751)CoolTouch LC215 Nd:YAG laser system(K072424)
Device Description:	The CoolTouch LC215/CoolLipo Surgical LaserSystem is an Nd:YAG laser producing laseremission at 1320 nm. The laser consists of acabinet which houses the power supply, thecooling system, microcontroller, laser, foot switch,and the fiber optic for delivery of the laser energywith microcannula setup.

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Intended Use:	In addition to previously cleared indications, theCooltouch LC215/CoolLipo is indicated for laser-assisted lipolysis.
Comparison:	The Cooltouch LC215/CoolLipo has the sameprinciple of operation, the same wavelength andessentially the same pulse energy rate as thepredicate devices.
Nonclinical Perfomance Data	None
Clinical Performance Data:	None
Conclusion:	The CoolTouch LC215/CoolLipo Nd:YAGSurgical Laser System is substantially equivalentto the predicate devices and is indicated for laser-assisted lipolysis.
Additional Information:	None requested at this time.

Regulation Number and Section

§ 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.