SKINTONER SYSTEM by FULLER RESEARCH CORP.

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 Description

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.

AI/ML Overview

This document is a 510(k) summary for a medical device called "SkinLaser System". It does not describe an acceptance criteria or a study proving that the device meets an acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to other existing devices on the market.

Therefore, I cannot extract the requested information from the provided text. The document does not contain:

A table of acceptance criteria and reported device performance.
Information on sample size or data provenance for a test set.
Details on experts used to establish ground truth.
Information on adjudication methods.
A multi-reader multi-case (MRMC) comparative effectiveness study.
A standalone algorithm performance study.
The type of ground truth used.
Training set sample size or how its ground truth was established.

The document primarily provides:

Device Identification: Trade Name (SkinLaser), Common Name (Surgical/Medical Solid State Laser System), 510(k) Number (K980501).
Substantial Equivalence Claim: The SkinLaser System is substantially equivalent to continuous wave (CW) and pulsed CW surgical lasers in the wavelength range of 800nm to 1064nm, and lists several predicate devices.
Indications for Use: Broad applications in general surgery, dermatologic and plastic surgery, gynecologic and urologic surgery, gastroenterology, and pulmonology.
FDA Clearance Letter: Confirms the device's substantial equivalence and class (Class II, product code GEX), and outlines regulatory responsibilities.

Summary

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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 (215) 885-2788

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

Submitted by:	Joseph A. Muccini, M.D.Medical and Regulatory Director
Contact:	Joseph A. Muccini, M.D. orTerry 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:

Company	Model / Power	Wavelength,Aiming beamwavelength	Other
Fuller ResearchCorporation	SkinLaser ST-25 25Wlaser	800-980nm,655nm aimingbeam	Proprietary fiberconnector, CW & Pulsed,internal cooling system,
Surgimedics, Diomed,Ltd.	Diomed 15W, 25W and60W laser	780 - 830nm,650nm aimingbeam	SMA fiber connector, CW& pulsed, internal coolingsystem
Applied OptronicsCorporation	AOC-25, 25W laser	980nm,655nm aimingbeam	SMA fiber connector, CW& Pulsed, internal coolingsystem
Indigo Medical, Inc.	Indigo 830, 20W laser	830nm,670nm aimingbeam	SMA fiber connector, CW& Pulsed, internal coolingsystem
Endocare Medical	DioLase 60, 60W laser	950-1010nm,red aimingbeam	SMA fiber connector, CW& Pulsed, internal coolingsystem

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 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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 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.

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

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

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.