The Fotona Fidelis Er.YAG Laser System and Accessories are intended for surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue. All soft tissue is included, such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, lymph vessels and nodes, organs, and glands

DermatologyPlastic Surgery : epidermal nevi, telangiectasia, spider veins, actinic chellitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors and cysts, skin resurfacing, superficial skin lesions, and performing diagnostic biopsies.

General Surgery : surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated

Genitourinary : lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon

Gynecology : cerivecal intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma

Oral Surgery : benign oral tumors, oral and glossal lesions and gingivottomy, gingivoplasty, frenectomy, sulcular debridement - removal of diseased or inflamed soft tissue in the periodontal pocket

Otorhinolaryngology(Head and Neck (ENT) : ear, nose and throat lesions, polyps, cysts, lyperkeratosis, excision of carcinogenic tissue and oral leukoplakia

Ophthalmology : soft tissue surrounding the eye and orbit anterior capsulotomy

Podiatry : warts, plantar verrucae, large mosaic verrucae and matrixectomy

Device Description

The Fotona Fidelis system is based on Er: YAG laser technology. Within the system, an optical cavity contains the Er: YAG crystal, which is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an articulated arm delivery system to a focusing handpiece. The laser is used in non-contact mode.

The System is capable of emitting up to 1.0 J of pulsed light at 2.94 um. This light has a pulsewidth which varies in the range 75 - 950 us. The laser is intended to be used for surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue. All soft tissue is included, such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.

The Fidelis system is designed with 5 major sub-systems:

a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.

b) A cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger.

c) An Er: Y AG laser rod, capable of generating 1.0 J optical pulses at a frequency up to 50 Hz.

d) An optical delivery system, interfacing the energy from the laser to the patient via an articulated arm and focusing handpiece.

e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.

Accessories available for use with Fotona SkinPlus:

· Fotona SkinScan Scanning Device (K970757)

AI/ML Overview

The provided text describes the Fotona Fidelis Er:YAG Laser System and its substantial equivalence to predicate devices, but it does not contain information regarding specific acceptance criteria for performance, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes for test/training sets, expert qualifications, or adjudication methods.

Instead, the document is a 510(k) premarket notification approval by the FDA, which focuses on demonstrating substantial equivalence to already legally marketed devices. The core of this submission is a comparison of the new device (Fotona Fidelis) to existing predicate devices (Laserscope Venus and Vela Erbium Laser Systems) based on their technological characteristics and intended use.

Here's a breakdown of what is and isn't present:

Information NOT Found in the Document:

A table of acceptance criteria and the reported device performance: This document does not specify quantitative performance metrics or acceptance thresholds for the Fotona Fidelis system (e.g., specific cutting speed, ablation depth, or coagulation efficacy values).
Sample sizes used for the test set and the data provenance: There is no mention of a test set, clinical trial, or any patient data used to evaluate the device's performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As no test set performance is discussed, ground truth establishment is not relevant in this document.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no test set data is presented.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is a laser system, not an AI-assisted diagnostic device, so an MRMC study is not relevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as it's a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical performance data is presented.
The sample size for the training set: Not applicable as no machine learning algorithm "training" is described.
How the ground truth for the training set was established: Not applicable.

Summary of the Document's Content Regarding Device Evaluation:

The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a new performance study with specific acceptance criteria.

The key arguments for substantial equivalence are:

Intended Use: The Fotona Fidelis system has the same intended use as the predicate devices (Laserscope Venus and Vela Erbium Laser Systems): "surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue. All soft tissue is included, such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands."
Technological Characteristics: The Fotona Fidelis has "identical characteristics" to the predicate devices, all of which are flashlamp-pumped Er:YAG lasers generating light at 2.94 um, delivered via an articulated arm and focusing handpiece.
Performance Comparison (Implicit): While no specific acceptance criteria are listed, the document states: "The Laserscope Venus Erbium Laser System has the ability to deliver laser energy at 2.94 microns, maximum power of 20 watts at repetition rate of up to 20 Hz. These characteristics are very similar to the Fotona Fidelis Erbium Laser System." This implicitly suggests that matching the power and repetition rate of the predicate device is a key performance characteristic considered for equivalence.
Safety and Effectiveness: "The risk and benefits for the Fotona Fidelis are comparable to the Laserscope Venus and Vela when used for similar clinical applications." The conclusion is that "there are no new questions of Safety or Effectiveness raised by the introduction of this device."

In essence, the "study" demonstrating the device meets "acceptance criteria" is the comparison to predicate devices, showing that it performs similarly to devices already approved for market, rather than a novel clinical trial against predefined performance thresholds. The FDA's approval letter (K990243) explicitly states the device is "substantially equivalent."

Summary

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Appendix E Summary of Safety and Effectiveness Data :

General Information and Description

K990243

g 1999 JUN

The Fidelis system is designed with 5 major sub-systems:

a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.

b) A cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger.

c) An Er: Y AG laser rod, capable of generating 1.0 J optical pulses at a frequency up to 50 Hz.

d) An optical delivery system, interfacing the energy from the laser to the patient via an articulated arm and focusing handpiece.

e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.

Accessories available for use with Fotona SkinPlus:

· Fotona SkinScan Scanning Device (K970757)

Summary of Substantial Equivalence

Fotona believes that its Fidelis system is substantially equivalent to the Laserscope Venus Erbium Laser System (EL Laser System) (K974896) and Laserscope Vela Erbium Laser System (K971843).

The Venus and Vela are cleared for surgical incision, cutting, ablation, vaporization, and coagulation of soft tissue. All soft tissue is included, such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. They therefore have the same Intended Use as the Fotona Fidelis.

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Technologically, the predicate devices have identical characteristics to the Fidelis, all three comprising a flashlamp pumped Er: YAG laser rod generating light at a wavelength of 2.94 um, which is subsequently delivered to the patient via an articulated delivery arm and focusing handpiece.

The risk and benefits for the Fotona Fidelis are comparable to the Laserscope Venus and Vela when used for similar clinical applications.

The Laserscope Venus Erbium Laser System has the ability to deliver laser energy at 2.94 microns, maximum power of 20 watts at repetition rate of up to 20 Hz. These characteristics are very similar to the Fotona Fidelis Erbium Laser System.

It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of this device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three lines forming its body and wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 0 1999

Moica Valjavec, Dipl. Eng. Product Manager Laser Division Fotona d.d. Stegne 7, 1210 Ljubljana Slovenia

Re: K990243

Trade Name: Fotona Fidelis Er: YAG Laser System and Accessories Regulatory Class: II Product Code: GEX Dated: April 26, 1999 Received: May 5, 1999

Dear Dr. Valjavec:

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 (QS) 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 - Mojca Valjavec, Dipl. Eng.

This letter will allow you to begin marketing your device as described in your 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 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,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and

Radiological Health

Enclosure

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APPENDIX F

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K990743

Device Name:

FOTONA FIDELIS Er:YAG LASER SYSTEM

Indications For Use:

Genitourinary : lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon

Gynecology : cerivecal intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma

Oral Surgery : benign oral tumors, oral and glossal lesions and gingivottomy, gingivoplasty, frenectomy, sulcular debridement - removal of diseased or inflamed soft tissue in the periodontal pocket ﺷﻬﺮ

Otorhinolaryngology(Head and Neck (ENT) : ear, nose and throat lesions, polyps, cysts, lyperkeratosis, excision of carcinogenic tissue and oral leukoplakia

Ophthalmology : soft tissue surrounding the eye and orbit anterior capsulotomy

Podiatry : warts, plantar verrucae, large mosaic verrucae and matrixectomy

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K990243

Prescription Use	X
(Per 21 CFR 801.109)
OR	Over-The-Counter Use

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.