Who is the manufacturer of MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO?

New Star Lasers, Inc. filed the 510(k) submission for MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO (K081628).

What is the FDA product code for MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO?

510(k) clearance (submission type: Special).

What are the predicate devices for MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO?

CoolTouch LC215/CoolTouch CoolLipo Nd:YAG Laser System.

Who can help prepare an FDA 510(k) submission like MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO

K081628 · New Star Lasers, Inc. · GEX · Jun 20, 2008 · General, Plastic Surgery

Device Facts

Record ID	K081628
Device Name	MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO
Applicant	New Star Lasers, Inc.
Product Code	GEX · General, Plastic Surgery
Decision Date	Jun 20, 2008
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended 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. 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.

Device Story

The CoolTouch LC225/CoolLipo is an Nd:YAG surgical laser system emitting at 1320nm. It comprises a cabinet housing a power supply, cooling system, microcontroller, and laser source, connected to fiber optics and a handpiece or JouleTracker. Operated by physicians in clinical settings, the device delivers laser energy to target tissues. The system provides hemostasis during soft tissue procedures and is used for dermatological treatments, vein reflux, and lipolysis. The microcontroller manages laser output parameters. Clinical benefit is derived from precise tissue interaction for surgical and aesthetic applications.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Nd:YAG surgical laser; 1320nm wavelength; includes power supply, cooling system, microcontroller, fiber optics, and handpiece/JouleTracker. Class II device.

Indications for Use

Indicated for patients requiring soft tissue incision, excision, ablation, or vaporization with hemostasis; treatment of fine lines, wrinkles, back acne, atrophic acne scars, varicose veins/varicosities (saphenous vein reflux), and laser-assisted lipolysis.

Regulatory Classification

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.

Predicate Devices

CoolTouch LC215/CoolTouch CoolLipo Nd:YAG Laser System

Related Devices

K080163 — COOLTOUCH MODELS LC215 AND COOLLIPO · New Star Lasers, Inc. · Apr 10, 2008
K072751 — COOLTOUCH MODELS NS 160 AND LC215 COOLIPO · New Star Lasers, Inc. · Jan 2, 2008
K072424 — COOLTOUCH, MODEL LC215,COOLLIPO · New Star Lasers, Inc. · Oct 3, 2007
K043046 — COOLTOUCH, MODEL CT3S · New Star Lasers, Inc. · Feb 1, 2005
K031184 — COOL TOUCH 3 · New Star Lasers, Inc. · May 21, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ K081628 JUN 2 0 2008 Page 14 ## 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. | | {1}------------------------------------------------ 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 {2}------------------------------------------------ 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 {3}------------------------------------------------ | 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 Page _1_ of _1_ Page 10 081628 510(k) Number_ Confidential 0010