COOLTOUCH VARIA ND:YAG LASER SYSTEM

K092964 · New Star Lasers, Inc. · GEX · Dec 11, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K092964
• Device Name: COOLTOUCH VARIA ND:YAG LASER SYSTEM
• Applicant: New Star Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The soft tissue applications are for the coagulation, photocoagulation, incision/excision, ablation, and vaporization of soft tissues including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Dermatology: For hair removal (destruction of hair follicles) in all skin types and for coagulation and hemostasis of vascular lesions and soft tissue applications. In addition to the tissue types cited, pigmented lesions to reduce lesion size; for patients with lesions that would potentially benefit from aggressive treatment; for patients with lesions that have not responded to other laser treatments. Also for the treatment of fine lines and wrinkles. Endoscopic/Laparoscopic General Surgery: Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in endoscopic, laparoscopic surgery applications, including but not limited to cholecystectomy, appendectomy, vagotomy, and pyloromyotomy. Gastroenterology: Tissue ablation and hemostasis in the Gl tract; esophageal neoplastic obstructions including squamous cell carcinoma and adenocarcinoma; GI hemostasis; including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, nonbleeding ulcers, gastric erosions, GI tissue ablation, including benign and malignant neoplasms, angiodysplasia; polyps, ulcer, colitis, and hemorrhoids. General Surgery: Soft tissue in general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation. Gynecology: Treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excision procedures such as conization of the cervix, intrauterine gynecologic procedures where cutting, ablation and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, uterine spetum. Head and Neck/Otorhinolaryngology (ENT): Coagulation, photocoagulation, incision/excision, ablation, and vaporization of soft tissue. Hemostasis during surgery: Adjunctive coagulation and hemostasis (control of bleeding) during surgery (endoscopic, laparoscopic, and open procedures). Neurosurgery: Hemostasis of pituitary tumor, meningioma, hemagioblastoma, AVMs, glioma, glioblastoma, astrocytoma, oligodendroglioma. Oculoplastics: Incision, excision, vaporization, ablation, and coagulation of soft tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of biopsy or orbital tumors, enucleation of the eyeball, exteneration of orbital contents. Orthopedics: Incision, excision, cutting, ablation and/or hemostasis of intra-articular tissue in orthopedic surgical and arthoscopic applications. Plastic Surgery: Incision, excision, cutting, coagulation, and vaporization of soft tissue. Pulmonary/Thoracic Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures. Thoracic Surgery: Incision, excision, cutting, coagulation, and vaporization of soft tissue, including lung tissue, in thoracic applications including but not limited to isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets. Urology: All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia (including condyloma accuminata). Podiatry: Ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neromas.

Device Story

CoolTouch Varia Nd:YAG laser system; 1064 nm wavelength emission. Cabinet houses power supply, cooling system, microcontroller, laser, foot switch; fiber optic handpiece delivers energy. Operated by clinicians in surgical/clinical settings. Device transforms electrical energy into laser output for soft tissue interaction (coagulation, ablation, incision). Output allows precise tissue management; benefits include hemostasis and targeted tissue removal. Clinician controls energy delivery via foot switch; visual feedback guides procedure. Enhances surgical precision; reduces bleeding; facilitates minimally invasive interventions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance comparison to predicate devices.

Technological Characteristics

Nd:YAG laser; 1064 nm wavelength. System includes cabinet, power supply, cooling system, microcontroller, and fiber optic delivery handpiece. Energy source: electrical. Connectivity: standalone. Sterilization: not specified.

Indications for Use

Indicated for soft tissue coagulation, photocoagulation, incision/excision, ablation, and vaporization across various surgical specialties including dermatology (all skin types), general, endoscopic/laparoscopic, GI, gynecological, ENT, neurosurgery, oculoplastics, orthopedic, plastic, thoracic, urological, and podiatric surgery. Applicable to patients requiring treatment for benign/malignant neoplasms, vascular lesions, pigmented lesions, and various soft tissue pathologies.

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 Varia Nd:YAG laser system
• Patholase PinPointe FootLaser Nd:YAG laser system
• Lumenis VersaPulse PowerSuite Ho:YAG/ Nd:YAG laser system

Submission Summary (Full Text)

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# DEC 11 2009

## Premarket Notification 510(k) Summary (As Required by 21 CFR 807.93)

K092964

This 510(k) Summary of safety and effectiveness for the New Star Model CoolTouch Varia 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(en.sommary.

| 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: | September 24, 2009 |
| Device Trade Name: | CoolTouch Varia 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<br>Devices: | CoolTouch Varia Nd:YAG laser system Patholase PinPointe FootLaser Nd:YAG laser system Lumenis VersaPulse PowerSuite Ho:YAG/ Nd:YAG laser system |
| Device Description: | The CoolTouch Varia Laser System is an Nd:YAG laser<br>producing laser emission at 1064 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: | The soft tissue applications are for the coagulation,<br>photocoagulation, incision/excision, ablation, and<br>vaporization of soft tissues including skin, cutaneous tissue,<br>subcutaneous tissue, striated and smooth tissue, muscle,<br>cartilage meniscus, mucous membrane, lymph vessels and<br>nodes, organs and glands.<br><br>Dermatology: For hair removal (destruction of hair follicles)<br>in all skin types and for coagulation and hemostasis of |

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vascular lesions and soft tissue applications. In addition to the tissue types cited, pigmented lesions to reduce lesion size; for patients with lesions that would potentially benefit from aggressive treatment; for patients with lesions that have not responded to other laser treatments. Also for the treatment of fine lines and wrinkles.

Endoscopic/Laparoscopic General Surgery: Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in endoscopic, laparoscopic surgery applications, including but not limited to cholecystectomy, appendectomy, vagotomy, and pyloromyotomy.

Gastroenterology: Tissue ablation and hemostasis in the Gl tract; esophageal neoplastic obstructions including squamous cell carcinoma and adenocarcinoma; GI hemostasis; including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, nonbleeding ulcers, gastric erosions, GI tissue ablation, including benign and malignant neoplasms, angiodysplasia; polyps, ulcer, colitis, and hemorrhoids.

General Surgery: Soft tissue in general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation.

Gynecology: Treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excision procedures such as conization of the cervix, intrauterine gynecologic procedures where cutting, ablation and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, uterine spetum.

Head and Neck/Otorhinolaryngology (ENT): Coagulation, photocoagulation, incision/excision, ablation, and vaporization of soft tissue.

Hemostasis during surgery: Adjunctive coagulation and hemostasis (control of bleeding) during surgery (endoscopic, laparoscopic, and open procedures).

Neurosurgery: Hemostasis of pituitary tumor, meningioma, hemagioblastoma, AVMs, glioma, glioblastoma, astrocytoma, oligodendroglioma.

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Oculoplastics: Incision, excision, vaporization, ablation, and coagulation of soft tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of biopsy or orbital tumors, enucleation of the eyeball, exteneration of orbital contents.

Orthopedics: Incision, excision, cutting, ablation and/or hemostasis of intra-articular tissue in orthopedic surgical and arthoscopic applications.

Plastic Surgery: Incision, excision, cutting, coagulation, and vaporization of soft tissue.

Pulmonary/Thoracic Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures.

Thoracic Surgery: Incision, excision, cutting, coagulation, and vaporization of soft tissue, including lung tissue, in thoracic applications including but not limited to isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets.

Urology: All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia (including condyloma accuminata).

Podiatry: Ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neromas.

The Cooltouch Varia has the same principle of operation, the same wavelength and essentially the same pulse energy rate as the predicate devices.

#### None

#### None

The CoolTouch Varia Nd:YAG Laser System is substantially equivalent to the predicate devices for the indications requested.

Additional Information:

Nonclinical Perfomance Data

Clinical Performance Data:

Comparison:

Conclusion:

None requested at this time.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control·Room W-O66-0609 Silver Spring, MD 20993-0002

New Star Lasers, Inc d.b.a. CoolTouch, Inc. % Ms. Natalie R. Vollrath QA/RA Manager 9085 Foothills Boulevard Roseville, California 95747

DEC 1 I 2009

Re: K092964

Trade/Device Name: CoolTouch Varia 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: Class II Product Code: GEX Dated: September 24, 2009 Received: September 25, 2009

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 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

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Page 2 - Ms. Natalie R. Vollrath

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Mark N. Melkerson
Director

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

510(k) Number:

09296

Device Name:

CoolTouch Varia Nd: YAG Laser System

### Indications for Use:

The soft tissue applications are for the coagulation, photocoagulation, incision/excision, ablation, and vaporization of soft tissues including skin, cutaneous tissue, subcutaneous tissue, strated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.

Dermatology: For hair removal (destruction of hair follicles) in all skin types. For coagulation and hemostasis of vascular lesions and soft tissue applications. In addition to the tissue types. cited, pigmented lesions to reduce lesion size; for patients with lesions that would potentially benefit from aggressive treatment; for patients with lesions that have not responded to other laser treatments. Also for the treatment of fine lines and wrinkles.

Endoscopic/Laparoscopic General Surgery: Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in endoscopic surgery applications, including but not limited to cholecystectomy, appendectomy, vagotomy, and pyloromyotomy.

***Continued on next page***

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)

Nixneogh far man

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

510(k) Number K092964

Page _1_of _3

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## Indications for Use-Continued

Gastroenterology: Tissue ablation and hemostasis in the GI tract; esophageal neoplastic obstructions including squamous cell carcinoma and adenocarcinoma; G1 hemostasis; including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions, GI tissue ablation, including benign and malignant neoplasms, angiodysplasia; polyps, ulcer, colitis, and hemorrhoids.

General Surgery: Soft tissue in general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, turnors, lesions, tissue ablation, vessel coagulation.

Gynecology: Treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excision procedures such as conization of the cervix, intra-uterine gynecologic procedures where cutting, ablation and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, uterine spetum.

Head and Neck/Otorhinolaryngology (ENT): Coagulation, photocoagulation, incision/excision, ablation, and vaporization of soft tissue.

Hemostasis during surgery: Adjunctive coagulation and hemostasis (control of bleeding) during surgery (endoscopic, laparoscopic, and open procedures).

Neurosurgery: Hemostasis of pituitary tumor, meningioma, hemagioblastoma, AVMs, glioma, glioblastoma, astrocytoma, oligodendroglioma.

Oculoplastics: Incision, excision, vaporization, ablation, and coagulation of soft tissues in oculoplastic procedures such as operations on the lacrimal or son the eyelids, removal of biopsy or orbital tumors, enucleation of the eyeball, openation of orbital contents.

Orthopedics: Incision, excision, cutting, ablation and/or hemostasis of intra-articular tissue in orthopedic surgical and arthoscopic applications.

Plastic Surgery: Incision, excision, cutting, coagulation, and vaporization of soft tissue.

Pulmonary/Thoracic Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions including squamous cell carcinoma, adenocarcinoma, carinoid, benignal vall wa granulomas, and benign strictures.

Thoracic Surgery: Incision, excision, cutting, coagulation, and vaporization of soft tissue, including lung tissue, in thoracic applications including but not limited to isol that of vessels for endarterectorny and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets.

Nuhhpal ***Continued on next page***

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

510(k) Number K092964

Page_2_of_3

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# Indications for Use-Continued

Urology: All applications including superficial urinary bladder tumors, invasive bladder carcina, urethral strictures, and lesions of the external genitalia (including condyloma accuminata).

Podiatry: Ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radic insul excision, and neromas.

NuthRP ofh for mikn

(Division Sign-Off) Division of Surgical, Orthopedic, ana Restorative Devices

510(k) Number KD92964