FOTONA SKINPLUS LASER SYSTEM by FOTONA D.D.

The Fotona SkinPlus Er. YAG surgical laser system is indicated for the cutting, ablation, vaporization, coagulation of soft tissue, and for skin resurfacing.

Device Description

The Totona SkinPlus 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 handoiece. The laser is used in non-contact mode.

The System is capable of emitting up to 2.0 J of pulsed light at 2,94 um. This light has a pulsewidth which varies in the range 100 - 500 us. The laser is intended to be used for curting, ablating, vaporizing, coagulating of soft tissue, and skin resurfacing.

The SkinPlus 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 tringgering 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 2.0 J optical pulses at a frequency up to 15 liz.

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

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

AI/ML Overview

The provided text is a 510(k) premarket notification for the Fotona SkinPlus Laser System. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for a novel device.

The core of this submission is to show that the Fotona SkinPlus has the same intended use and technological characteristics as its predicate devices, the Continuum Diomedical (Con-Dio) CB Erbium/2.94 Er:YAG laser (K970934) and the Fotona Skinlight laser system (K962902).

Therefore, there isn't a "study" with specific acceptance criteria and reported device performance in the way one might expect for a new performance claim. Instead, the "acceptance criteria" are effectively that the device's characteristics and intended use align with those of the cleared predicate devices, thereby ensuring no new questions of safety or effectiveness are raised.

Given this context, here's how the requested information would apply:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

Since this is a 510(k) submission for substantial equivalence rather than a de novo approval requiring extensive performance studies, the "acceptance criteria" relate to the comparison with predicate devices.

Acceptance Criteria	Reported Device Performance (vs. Predicate Devices)
Intended Use	Same as predicate devices (cutting, ablation, vaporization, coagulation of soft tissue, and skin resurfacing). The CB Erbium/2.94 is cleared for skin resurfacing in the treatment of wrinkles. The Skinlight is cleared for cutting, ablation, vaporization, and coagulation of soft tissue.
Technological Characteristics	Er:YAG laser rod: Flashlamp pumped, generating light at 2940 nm.
	Delivery System: Articulated arm and focusing handpiece.
	Energy Delivery: Identical energy delivery capabilities as CB Erbium/2.94.
	Repetition Rates: Similar repetition rates as CB Erbium/2.94.
	Energy Level: Fotona SkinPlus maintains energy levels to match or be consistent with predicate devices, particularly the CB Erbium/2.94, which is cleared for skin resurfacing.
Safety and Effectiveness	No new questions of Safety or Effectiveness are raised compared to the predicate devices.

Additional Information on the "Study" (Substantial Equivalence Justification)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a traditional performance study. The "test set" here refers to the comparison of the Fotona SkinPlus's specifications and intended use against those of the predicate devices. No patient or sample data is presented for performance testing.
- Data Provenance: The data provenance for the predicate devices' clearance would have been from their original submissions, but details are not provided in this document. This submission itself is from Slovenia (Fotona d.d.), and the review is by the US FDA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as typically understood in performance studies (e.g., disease presence/absence confirmed by pathology or clinical outcome) is not established here. The "truth" is the regulatory status and specifications of the predicate devices a priori. The FDA (specifically the Division of General and Restorative Devices) acts as the expert body confirming substantial equivalence.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring adjudication of individual cases. The FDA's review process serves as the adjudication, where they assess the entire submission for substantial equivalence.
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:
- Not applicable. This is a laser system, not an AI-powered diagnostic device. No MRMC study was performed or required for this type of submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device, not an algorithm. Therefore, "standalone" performance in the AI sense does not apply.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this 510(k) submission is the regulatory clearance and established safety/effectiveness profile of the predicate devices. The Fotona SkinPlus leverages the existing "truth" that similar devices (Er:YAG lasers) are safe and effective for the stated indications when used appropriately.
The sample size for the training set:
- Not applicable. There is no machine learning or AI component requiring a training set.
How the ground truth for the training set was established:
- Not applicable, as no training set exists.

Summary

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K980560 MAR 2 7 1998

Appendix E Summary of Safety and Effectiveness Data :

General Information and Description

The SkinPlus 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 tringgering 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 2.0 J optical pulses at a frequency up to 15 liz.

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

e) The microproccssor 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 (K.970757)
· Fotona Skinlight Plus Nd. VAG System (K972368)

Summary of Substantial Equivalence

Fotona believes that its SkinPlus system is substantially equivalent to the Continuum Diomedical (Con-Dio) CB Erbium/2.94 Er: YAG laser (K970934) and is an upgrade of the the Fotona Skinlight lascr system, previously cleared under K962902.

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The CB Erbium/2.94 is cleared for skin resurfacing in the treatment of wrinkles, whereas the Skinlight is cleared for the cutting, ablation, vaporization, and coagulation of soft tissue. They therefore have the same Intended Use as the Fotona SkinPlus.

Technologically, the predicate devices have identical characteristics to the Fotona SkinPlus, both comprising a flashlamp pumped Er: YAG laser rod generating light at a wavelength of 2940 nm, which is subsequently delivered to the patient via an articulated arm and focusing handpiece.

The CB Erbium/2.94 and the Fotona SkinPlus have identical energy delivery capabilities and similar repetition rates. The SkinPlus and the Skinlight are sharing all characteristics except the energy level.

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 consists of a stylized eagle with three stripes representing the department's services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

MAR 27 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mojca Valjavec, Dipl.Eng. Marketing and Sales Department Laser Division Fotona d.d. Stegne 7 1210 Ljubljana, Slovenia

Re: K980560 Trade Name: Fotona SkinPlus Laser System Regulatory Class: II Product Code: GEX Dated: January 30, 1998 Received: February 13, 1998

Dear Ms. 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 Requlations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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 requlations.

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Page 2 - Ms. Valjavec

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,

C. Nic. M. Whitten, Ph.D.

Dia 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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510(k) Number (if known):	K980560
Device Name:	FOTONA SKINPLUS LASER SYSTEN

Indications For Use:

The Fotona SkinPlus Er. YAG surgical laser system is indicated for the cutting, ablation, vaporization, coagulation of soft tissue, and for skin resurfacing. ----

(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	K980560

Prescription Use Y (Per 21 CFR 801.109) OR

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.