The Fotona Tandem Laser System and Accessories is intended for incision, ablation, vaporization, coagulation, and hemostasis of vascular lesions and soft tissue in various surgical areas, and for permanent hair reduction in Fitzpatrick skin types I-V1.

KTP Laser (532 + 1064 nm)
The Fotona Tandem KTP laser is intended for incision, vaporization, coaqulation, and hemostasis of vascular lesions and soft tissue in vanous surgical areas. 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. Dermatology :
The treatment (hemostasis, color lightening, blanching, reduction of lesion size) of the vascular lesions (Angiomas, Hemangiomas, Telangiectasia)

Nd:YAG Laser (1064 nm)
The Tandem Nd:YAG laser systems is indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialities of general and plastic surgery and dermatology:

To effect stable long-term, or permanent, hair reduction in skin types I VI through selective . targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
For removal of unwanted hair. ●
For coaqulation and hemostasis of vascular lesions. ●
For incision/excision of soft body tissue in dermatology. ●
For soft tissue general surgery applications skin incision; tissue dissection; complete or ● partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation.

Device Description

The Fotona Tandem laser system is based on the Nd: YAG (1064 nm) and KTP (532 nm) laser technology. There are two optical cavities containing the Nd:YAG and KTP crystals. Both are activated by means of the use of flashlamps. After each cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided through the optical fiber delivery systems to the focusing handpieces.

Both lasers are used in non-contact mode.

Both laser heads share a common power supply, control system, and cooling system. The internal computer can be directed to select either the Nd: Y AG head or the KTP (Inixedwavelength 1064/532 nm) head. When the laser is first turned on the physician is able to select the desired wavelength via control panel.

AI/ML Overview

This is a 510(k) premarket notification for a laser system. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study to establish new acceptance criteria and prove its performance. Therefore, many of the requested categories of information related to a study proving the device meets acceptance criteria will not be present in this document.

Here's a breakdown of what can be extracted and what cannot be, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. This document does not establish new acceptance criteria or report specific device performance data from a clinical trial designed to meet those criteria. The submission is based on demonstrating substantial equivalence to existing predicate devices.

2. Sample size used for the test set and the data provenance:

Not applicable. No separate "test set" in the context of a clinical performance study is described. The demonstration of substantial equivalence relies on comparing the technical characteristics and intended uses of the new device with existing, legally marketed predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No "ground truth" for a test set in the context of a study is established or described.

4. Adjudication method for the test set:

Not applicable. There is no described test set or adjudication method.

5. 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 device is a laser system, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies or AI assistance are not relevant to its regulatory submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a laser system, meaning there is no "algorithm only" performance to evaluate.

7. The type of ground truth used:

Not applicable. No new "ground truth" was established for this submission. The "ground truth" for demonstrating substantial equivalence is the safety and effectiveness of the predicate devices.

8. The sample size for the training set:

Not applicable. There is no information about a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable.

Information that is relevant and can be extracted:

I. General Information:

Company: Fotona d.d.
Contact Person: Mojca Valjavec
Preparation Date: 08-08-02
Device Trade Names: Fotona Tandem Laser System
Common Name: Combination of Long Pulse Nd:YAG and Nd:YAG/KTP Lasers
Classification Name: Instrument, Surgical, Powered, Laser
Regulatory Class: Class II
Product Code: GEX
Regulation Number: 21 CFR 878.4810

II. Description of the Device:

The Fotona Tandem laser system combines Nd:YAG (1064 nm) and KTP (532 nm) laser technology.
It has two optical cavities, activated by flashlamps.
A red diode aiming beam is reflected onto a coaxial beam path.
Therapeutic and aiming beams are guided through optical fiber delivery systems to focusing handpieces.
Both lasers are used in non-contact mode.
They share a common power supply, control system, and cooling system.
The system allows selection of either the Nd:YAG or KTP (mixed wavelength 1064/532 nm) head via a control panel.

III. Intended Use and Indications for Use (as stated in Appendix F):

General: Incision, ablation, vaporization, coagulation, and hemostasis of vascular lesions and soft tissue in various surgical areas, and for permanent hair reduction in Fitzpatrick skin types I-VI.
KTP Laser (532 + 1064 nm): Incision, vaporization, coagulation, and hemostasis of vascular lesions and soft tissue in various surgical areas. All soft tissue is included (e.g., skin, cutaneous tissue, subcutaneous tissue, muscle, cartilage, mucous membrane, lymph vessels and nodes, organs, glands).
- Dermatology: Treatment (hemostasis, color lightening, blanching, reduction of lesion size) of vascular lesions (Angiomas, Hemangiomas, Telangiectasia).
Nd:YAG Laser (1064 nm): Surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in general and plastic surgery and dermatology.
- To effect stable long-term, or permanent, hair reduction in skin types I-VI through selective targeting of melanin in hair follicles. (Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.)
- For removal of unwanted hair.
- For coagulation and hemostasis of vascular lesions.
- For incision/excision of soft body tissue in dermatology.
- For soft tissue general surgery applications (skin incision; tissue dissection; complete or partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation).

IV. Summary of Substantial Equivalence (instead of acceptance criteria and study):

Fotona believes its Tandem laser system is substantially equivalent to:
- Fotona Dualis " long pulse KTP laser system (previously cleared for incision, ablation, vaporization, coagulation, and hemostasis of vascular lesions and soft tissue).
- Fotona Dualis' Nd:YAG laser system (previously cleared for permanent hair reduction in Fitzpatrick skin types I-VI).
- Palomar Clear Light Nd:YAG laser system (marketed as Palomar Q-YAG 5, which incorporates dual wavelengths 1064 and 1064/532 nm and was cleared for treatment of vascular lesions and hair removal).
Basis for Equivalence:
- Same Intended Use as the predicate devices.
- Shares similar/same design features: wavelength, active medium, cooling system, power supply, beam deliveries, controls, housing.
- Risk and benefits are comparable to predicate devices for similar clinical applications.
Conclusion: No new questions of safety or effectiveness are raised.

In summary, this document is a 510(k) submission, which means the device is being cleared based on its substantial equivalence to already legally marketed devices. It does not involve a de novo study to establish new acceptance criteria or gather performance data against them.

Summary

{0}------------------------------------------------

K 022837

I. General Information

Summary of Safety and Effectiveness Data Appendix E:

NOV 2 5 2002

1/>

Company :	Fotona d.d.Stegne 7, 1210 LjubljanaSLOVENIA
Contact Person :	Mojca Valjavec
Preparation Date :	08-08-02
Device Trade Names :	Fotona Tandem Laser System
Common Name :	Combination of Long Pulse Nd:YAG andNd:YAG/KTP Lasers
Classification Name :	Instrument, Surgical, Powered, Laser79-GEX21 CFR 878-48

II. Description

Both lasers are used in non-contact mode.

III. Intended Use

{1}------------------------------------------------

IV. Summary of Substantial Equivalence

Fotona believes that its Tandem laser system is substantially equivalent to the Fotona Dualis " long pulse KTP laser system previously cleared for incision, ablation, vaporization, coagulation, and hemostasis of vascular lesions and soft tissue in various surgical areas, to the Fotona Dualis' Nd:YAG laser system previously cleared also for permanent hair reduction in Fitzpatrick skin types I - VI, and to the Palomar Clear Light Nd:YAG laser system, marketed under Palomar Q-YAG 5. Similar as the Fotona Tandem, the Palomar system incorporates dual wavelengths (1064 and 1064/532 nm) and has been cleared for treatment of vascular lesions and removal of hair.

They therefore have the same Intended Use as the Fotona Tandem laser system.

The Tandem laser system shares the same design features (wavelength, active medium, cooling system, power supply, beam deliveries, controls, housing) as the Fotona Dualis " and the Fotona Dualis YP.

The risk and benefits for the Tandem laser system are comparable to the predicate devices when used for similar clinical applications.

It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of the Tandem laser system.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract graphic consisting of three stylized human profiles facing to the right, stacked one above the other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 5 2002

Fotona D. D Moica Valiavec OA/RA Manager Stegne 7, 1210 Ljubljana Slovenia

Re: K022837

Trade/Device Name: Fotona Tandem Laser System Regulation Number: 878.4810 Regulation Name: Instrument, surgical, powered, laser Regulatory Class: Class II Product Code: GEX Dated: August 20, 2002 Received: August 27, 2002

Dear Sir or Madam:

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 such 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the

{3}------------------------------------------------

. Page 2 - Sir or Madam

quality systems (OS) regulation (21 CFR Part 820); and if applicable; the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 5100k) 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), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

(Celia M. Witten, Ph.D., MD., MD.
Director Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Appendix F : Indications for Use Statement

510(k) Number (if known): KO22837

Device Name:

Fotona Tandem Nd: YAG/KTP Laser System and Accessories

Indications For Use:

KTP Laser (532 + 1064 nm)

The Fotona Tandem KTP laser is intended for incision, vaporization, coaqulation, and hemostasis of vascular lesions and soft tissue in vanous surgical areas. 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. Dermatology :

The treatment (hemostasis, color lightening, blanching, reduction of lesion size) of the vascular lesions (Angiomas, Hemangiomas, Telangiectasia)

Nd:YAG Laser (1064 nm)

The Tandem Nd:YAG laser systems is indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialities of general and plastic surgery and dermatology:

To effect stable long-term, or permanent, hair reduction in skin types I VI through selective . targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
For removal of unwanted hair. ●
For coaqulation and hemostasis of vascular lesions. ●
For incision/excision of soft body tissue in dermatology. ●
For soft tissue general surgery applications skin incision; tissue dissection; complete or ● partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation.

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
	Miriam C. Provost
	(Division Sign-Off)
	Division of Gen. 1. Restorativeand Neurological Devices
Prescription Use(Per 21 CFR 801.109)	510(k) Number OR K022837 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.