COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE

K101783 · New Star Lasers, Inc. · GEX · Sep 13, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K101783
• Device Name: COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE
• Applicant: New Star Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 13, 2010
• Decision: SESE
• Submission Type: Traditional
• 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 treatment of fine lines and wrinkles; for mild to moderate inflammatory acne vulgaris; for back acne and atrophic scarring, and; for podiatry, (incision, excision, and coagulation of soft tissue) including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas.

Device Story

CoolTouch CT3PZ is an Nd:YAG surgical laser system emitting at 1320 nm. System comprises a cabinet housing power supply, cooling system, microcontroller, laser source, and foot switch; energy delivered via fiber optic handpiece. Operated by clinicians in dermatology and podiatry settings for soft tissue procedures. Device transforms electrical energy into laser light for tissue interaction (incision, excision, ablation, coagulation). Output is controlled laser energy; clinician directs handpiece to target tissue. Provides hemostasis during procedures; benefits include precise tissue management for dermatological and podiatric conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing data indicating effectiveness for podiatry applications.

Technological Characteristics

Nd:YAG surgical laser; 1320 nm wavelength. System includes cabinet, power supply, cooling system, microcontroller, and fiber optic delivery handpiece. Operated via foot switch. Class II device.

Indications for Use

Indicated for dermatology patients requiring soft tissue incision, excision, ablation, or vaporization; treatment of fine lines, wrinkles, mild-to-moderate inflammatory acne vulgaris, back acne, and atrophic acne scars; and podiatry patients requiring soft tissue procedures including matrixectomy, wart removal (periungal, subungal, plantar), radical nail excision, and neuroma treatment.

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 CT3 Nd:YAG laser system
• CoolTouch CT3S Nd:YAG laser system
• CoolTouch Varia Nd:YAG laser system
• Patholase PinPointe FootLaser Nd:YAG laser system

Submission Summary (Full Text)

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K/01783

SEP 1 3 2010

## 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 CT3PZ/CoolTouch CT3 Plus CoolBreeze 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.

| Submitter: | New Star Lasers, Inc. d.b.a. CoolTouch, Inc. |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 9085 Foothills Boulevard<br>Roseville, CA 95747 |
| Contact Person: | Natalie Vollrath<br>Quality and Regulatory Manager |
| Telephone/Fax/Email: | [phone] - Phone<br>[phone] - Fax<br>[e-mail] - Email |
| Date prepared: | June 24, 2010 |
| Device Trade Name: | CoolTouch CT3PZ/CoolTouch CT3 Plus CoolBreeze<br>Nd:YAG Surgical Laser |
| Common Name: | Nd: YAG Surgical Laser |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX -<br>21 CFR §878.4810 |
| Legally Marketed Predicate Devices: | <ul><li>CoolTouch CT3 Nd:YAG laser system</li><li>CoolTouch CT3S Nd:YAG laser system</li><li>CoolTouch Varia Nd:YAG laser system</li><li>Patholase PinPointe FootLaser Nd:YAG laser system</li></ul> |
| Device Description: | The CoolTouch CT3PZ Laser System is an Nd:YAG laser<br>producing laser emission at 1320 nm. The laser consists of a<br>cabinet which houses the power supply, the cooling system,<br>microcontroller, laser, foot switch, and the fiber optic for<br>delivery of the laser energy with fiber optic handpiece setup. |
| Intended Use: | For use in dermatology for incision, excision, ablation, and<br>vaporization with hemostasis of soft tissue; for treatment of<br>fine lines and wrinkles; for mild to moderate inflammatory<br>acne vulgaris; for back acne and atrophic scarring, and; for<br>podiatry, (incision, excision, and coagulation of soft tissue)<br>including matrixectomy, periungal and subungal warts,<br>plantar warts, radical nail excision, and neuromas. |

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| Comparison: | The Cooltouch CT3PZ has the same principle of operation,<br>the same wavelength and essentially the same pulse energy<br>rate as the predicate devices. |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Nonclinical Performance Data | Bench testing data produced results that indicate the CT3PZ<br>is effective for use in podiatry. |
| Clinical Performance Data: | None |
| Conclusion: | The CoolTouch CT3PZ Nd:YAG Laser System is<br>substantially equivalent to the predicate devices for the<br>indications requested. |
| Additional Information: | None requested at this time. |

:

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

SEP 1 8 2010

Re: K101783

Trade/Device Name: CoolTouch CT3PZ/CoolTouch CT3 Plus CoolBreeze Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: September 02, 2010 Received: September 07, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you: however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Ms. Natalie R. Vollrath

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

K101783

-

510(k) Number

SEP 1 8 2010

| Device Name | CoolTouch CT3PZ/CoolTouch CT3 Plus CoolBreeze | |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Indications for<br>Use | The CoolTouch Model CT3PZ Nd:YAG Surgical Laser is<br>indicated for the following: | |
| | for use in dermatology for incision, excision, ablation and<br>•<br>vaporization with hemostasis of soft tissue; | |
| | for treatment of fine lines and wrinkles; | |
| | for treatment of mild to moderate inflammatory acne<br>•<br>vulgaris; | |
| | for treatment of back acne and atrophic acne scars, and; | |
| | for podiatry (ablation, vaporization, incision, excision, and<br>coagulation of soft tissue) including:<br>o matrixectomy<br>o periungal and subungal warts<br>o plantar warts<br>o radical nail excision<br>o neuromas | |
| Prescription Use __________X__________<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-the-Counter Use__________<br>(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)

Neil RP dyke for mxm
(sin off)

(Division Sign-Off) (Division Sign-Olf)
Division of Surgical, Orthopedic, Orthopedic, Division of Surgices Division of Sure
and Restorative Devices

510(k) Number K101783

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