SKINTONER SYSTEM

K980501 · Fuller Research Corp. · GEX · Jul 8, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980501
• Device Name: SKINTONER SYSTEM
• Applicant: Fuller Research Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SkinLaser System is indicated for incision, excision, coagulation and vaporization of soft tissue. In general surgery, dermatologic and plastic surgery, all soft tissues are included in this indication: skin, subcutis, breast, abdominal and striated and smooth muscle, tendon and fascia, cartilage, mucous membrane, lymph vessels and nodes, and internal organs and glands. In gynecologic and urologic surgery indications include endoscopic, intraabdominal and externally accessed (free-hand) gynecological and urological tissues, structures, obstructions, strictures, tumors, and other lesions. Only palliative treatment and partial removal of neoplastic tissue should be assumed. In gastroenterology indications include destruction of polyps, lesions, varices, tumors, and for treatment of hemorrhages. In pulmonology surgery indications include flexible or a rigid endoscopic and free-hand access and treatment of soft tissue lesions, obstructions, tracheal stenosis, and tumors.

Device Story

SkinLaser is a solid-state surgical laser system; operates in 800-980nm wavelength range; delivers continuous wave (CW) or pulsed laser energy to soft tissue via contact or non-contact delivery devices. Used by physicians in OR or clinical settings for incision, excision, coagulation, and vaporization. Includes internal cooling system and 655nm aiming beam. Physician controls laser output to achieve desired tissue effect; provides precise thermal energy for surgical procedures; benefits include controlled tissue destruction and hemostasis.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Solid-state laser system; wavelength 800-980nm; 655nm aiming beam; CW and pulsed modes; internal cooling system; proprietary fiber connector; delivery via contact or non-contact devices.

Indications for Use

Indicated for incision, excision, coagulation, and vaporization of soft tissue across general, dermatologic, plastic, gynecologic, urologic, gastroenterologic, and pulmonologic surgical specialties. Includes treatment of lesions, tumors, obstructions, and hemorrhages. Palliative use only for neoplastic tissue.

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

• Diomed 15W, 25W and 60W laser
• AOC-25, 25W laser
• Indigo 830, 20W laser
• DioLase 60, 60W laser

Submission Summary (Full Text)

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Page 3 of 7 Jul 7, 1998 11:53:44 a.m.

K980501

8 1998 11 11

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## ESEARCH CORPORATION

Fex [phone]

PREMARKET NOTIFICATION [510(k)] SUMMARY As required by section 807.97(c)

| Submitted by: | Joseph A. Muccini, M.D.<br>Medical and Regulatory Director |
|----------------------------|------------------------------------------------------------|
| Contact: | Joseph A. Muccini, M.D. or<br>Terry A. Fuller, Ph.D. |
| Date Prepared: | June 17, 1998 |
| 510(k) Number: | K980501 |
| Trade or Proprietary Name: | SkinLaser |
| Common or Usual Name: | Surgical/Medical Solid State Laser System |

Equivalence:

The SkinLaser System is substantially equivalent to continuous wave (CW) and pulsed CW surgical lasers in the wavelength range of 800nm to 1064nm. Such systems have been in surgical use for many years offering broad multi-specialty, multi-procedure applications. The laser deliver system includes both contact and non-contact devices. The following chart is a partial list of equivalent products currently marketed by other manufacturers.

| Company | Model / Power | Wavelength,<br>Aiming beam<br>wavelength | Other |
|----------------------------------|----------------------------------|------------------------------------------|--------------------------------------------------------------------------|
| Fuller Research<br>Corporation | SkinLaser ST-25 25W<br>laser | 800-980nm,<br>655nm aiming<br>beam | Proprietary fiber<br>connector, CW & Pulsed,<br>internal cooling system, |
| Surgimedics, Diomed,<br>Ltd. | Diomed 15W, 25W and<br>60W laser | 780 - 830nm,<br>650nm aiming<br>beam | SMA fiber connector, CW<br>& pulsed, internal cooling<br>system |
| Applied Optronics<br>Corporation | AOC-25, 25W laser | 980nm,<br>655nm aiming<br>beam | SMA fiber connector, CW<br>& Pulsed, internal cooling<br>system |
| Indigo Medical, Inc. | Indigo 830, 20W laser | 830nm,<br>670nm aiming<br>beam | SMA fiber connector, CW<br>& Pulsed, internal cooling<br>system |
| Endocare Medical | DioLase 60, 60W laser | 950-1010nm,<br>red aiming<br>beam | SMA fiber connector, CW<br>& Pulsed, internal cooling<br>system |

The function and features of the SkinLaser System is equivalent to or identical to currently marketed devices. Thus, the SkinLaser System is not a "new" device and can be marketed for the Indications for Use as systems currently marked.

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## PREMARKET NOTIFICATION [510(k)] SUMMARY (Continued)

Indications for Use include:

The SkinLaser System is indicated for incision, excision, coagulation and vaporization of soft tissue.

In general surgery, dermatologic and plastic surgery, all soft tissues are included in this indication: skin, subcutis, breast, abdominal and striated and smooth muscle, tendon and fascia, cartilage, mucous membrane, lymph vessels and nodes, and internal organs and glands.

In gynecologic and urologic surgery indications include endoscopic, intraabdominal and externally accessed (free-hand) gynecological and urological tissues, structures, obstructions, strictures, tumors, and other lesions. Only palliative treatment and partial removal of neoplastic tissue should be assumed.

In gastroenterology indications include destruction of polyps, lesions, varices, tumors, and for treatment of hemorrhages.

In pulmonology surgery indications include flexible or a rigid endoscopic and free-hand access and treatment of soft tissue lesions, obstructions, tracheal stenosis, and tumors.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1998 . Il Jl

Terry A. Fuller, Ph.D. · President Fuller Research Corporation 944 Mogan Road Rydal, Pennsylvania 19046

Re: K980501 Trade Name: Skin Laser System Regulatory Class: II Product Code: GEX Dated: May 27, 1998 Received: May 29, 1998

## Dear Dr. Fuller:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Dr. Terry Fuller

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

ia M. Witten, Ph.D., M.D. Cel Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: Device Name:

K980501 SkinLaser System Page 1 of 1

Indications for Use:

The SkinLaser System is indicated for incision, excision, coagulation and vaporization of soft tissue.

In general surgery, dermatologic and plastic surgery, all soft tissues are included in this indication: skin, subcutis, breast, abdominal and striated and smooth muscle, tendon and fascia, cartilage, mucous membrane, lymph vessels and nodes, and internal organs and glands.

In gynecologic and urologic surgery indications include endoscopic, intraabdominal and externally accessed (free-hand) gynecological and urological tissues, structures, obstructions, strictures, turnors, and other lesions. Only palliative treatment and partial removal of neoplastic tissue should be assumed.

In gastroenterology indications include destruction of polyps, lesions, varices, tumors, and for treatment of hemorrhages.

In pulmonology surgery indications include flexible or a rigid endoscopic and free-hand access and treatment of soft tissue lesions, obstructions, tracheal i stenosis, and turnors.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

|--|--|

| (Division Sign-Off) | |
|------------------------------------------|---------|
| Division of General Restorative Devices/ | |
| 510(k) Number | 9800501 |

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)