Nd:YAG Laser (1064 nm): The Fotona Dualis Nd:YAG laser is intended for incision, ablation, vaporization coagulation and hemostasis of vascular lesions and soft tissue in various surgical areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI.
Er:YAG Laser (2940 nm): The Fotona Dualis® Er:YAG laser is intended for surgical incision/excision, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, subcutaneous tissue, striated and smooth tissue, cartilage meniscus, muscle, mucous membrane, lymph vessels and nodes, organs and glands.

Device Description

The Fotona Dualis 8 laser system is based on the Nd:YAG (1064 nm) and Er:YAG (2940 nm) laser technology. It is modification to combine two lasers into one housing. The unmodified devices are the Fotona Fidelis Er:YAG laser and the Fotona Dualis' " Nd:YAG laser system. There are two optical cavities containing the Nd:YAG and Er:YAG 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:

. In case of the Nd: YAG laser through an optical fiber delivery system to a focusing handpiece.
In case of the Er: Y AG laser through articulated arm to a focusing handpiece. ●
Both lasers share a common power supply, control system, and cooling system. The internal computer can be directed to select either the Er.YAG laser source or the Nd:YAG laser source. When the laser is first turned on the physician is able to select the desired wavelength via control panel.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Fotona Dualis® Nd:YAG/Er:YAG Laser System:

It's important to note that the provided text is a 510(k) Premarket Notification summary, not a detailed clinical study report. Therefore, it focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting primary clinical trial data with specific acceptance criteria and performance metrics for the new device as a standalone entity.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, the "acceptance criteria" for this 510(k) submission are fundamentally based on substantial equivalence to predicate devices. There are no explicit quantitative performance metrics or acceptance criteria for the new device itself outlined in the document, outside of its operational characteristics being the same as the predicates.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Devices:	Met:
- Same Intended Use as Predicate (Fotona Dualis Nd:YAG and	- "They therefore have the same Intended Use as the Fotona Dualised laser system."
Fotona Fidelis Er:YAG).	- "The Fotona Dualis® Nd:YAG laser is indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in general and plastic surgery and dermatology. In addition, the family is indicated to effect stable long-term, or permanent hair reduction in Fitzpatrick skin types I - VI through selective targeting of melanin in hair follicles..."
	- "The Fotona Dualis® Er:YAG laser is indicated for incision/excision, cutting, ablation, vaporization, and coagulation of soft and hard tissue in various surgical areas."
- Shares same design features (wavelength, active medium, etc.)	- "The Dualis Nd:YAG/Er:YAG laser system shares the same design features (wavelength, active medium, cooling system, power supply, beam deliveries, controls, housing) as the predicate devices."
- Output characteristics are the same.	- "The output characteristics are the same as those of the predicate devices."
- Comparable risks and benefits.	- "The risk and benefits for the Dualis 9 laser system are comparable to the predicate devices when used for similar clinical applications."
- No new questions of Safety or Effectiveness.	- "It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of the Dualis 80 Nd:YAG/Er:YAG laser system."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. The document describes a substantial equivalence (510(k)) submission, not a clinical study with a "test set" in the traditional sense of evaluating patient outcomes with the new device. The "test" here is a comparison of the new device's specifications and intended use against existing predicate devices.
Data Provenance: Not applicable for a primary clinical test set of the new device. The data provenance referenced is the prior clearance of the predicate devices (Fotona Dualis Long Pulse Nd:YAG and Fotona Fidelis Er:YAG laser systems). This indicates historical data and regulatory decisions, not new clinical studies on the Dualis® Nd:YAG/Er:YAG Laser System.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. As this is a substantial equivalence submission, there isn't a "ground truth" derived from expert consensus on patient outcomes for this specific new device. The "ground truth" for the comparison is the established safety and effectiveness of the predicate devices, as determined by prior FDA clearances.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set involving adjudication of outcomes exists for this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. An MRMC comparative effectiveness study was not done or reported in this document. This type of study is typically associated with diagnostic devices, where multiple readers interpret cases with and without AI assistance to measure improvements in diagnostic accuracy. This document is for a therapeutic laser system.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Yes, in a way, the entire 510(k) submission is assessing the "standalone" performance of the new device against its predicates. The device itself is the standalone "algorithm" (laser system) in this context. The claim is that its operational characteristics and output are equivalent to the previously cleared devices. There's no "human-in-the-loop" concept applicable here as it's a direct therapeutic device.

7. The Type of Ground Truth Used

The "ground truth" used is the documented safety and effectiveness of the predicate devices as established during their prior FDA clearance processes. This relies on the regulatory history and body of evidence supporting those previously cleared devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a "training set." The device is a medical laser system. The "training" for the substantial equivalence claim comes from the existing safety and effectiveness data and regulatory clearances of the predicate devices.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set." The "ground truth" for proving substantial equivalence relies on the historical regulatory evaluations and approvals of the predicate devices by the FDA. This would have involved the predicate devices themselves meeting their own specific performance criteria and demonstrating safety and effectiveness for their intended uses.

Summary

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Summary of Safety and Effectiveness Data

I. General Information

DEC 0 6 2002

Company :	Fotona d.d.Stegne 7, 1210 LjubljanaSLOVENIA
Contact Person :	Mojca Valjavec
Preparation Date :	05-03-02
Device Trade Names :	Fotona Dualis SP Nd:YAG/Er:YAG Laser System
Common Name :	Combination of Long Pulse Nd:YAG and Er:YAGLasers
Classification Name :	Instrument, Surgical, Powered, Laser79-GEX21 CFR 878-48

II. Description

. In case of the Nd: YAG laser through an optical fiber delivery system to a focusing handpiece.
In case of the Er: Y AG laser through articulated arm to a focusing handpiece. ●

Both lasers share a common power supply, control system, and cooling system. The internal computer can be directed to select either the Er.YAG laser source or the Nd:YAG laser source. When the laser is first turned on the physician is able to select the desired wavelength via control panel.

III. Intended Use

The Fotona Dualis® Nd:YAG laser is indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in general and plastic surgery and dermatology. In addition, the family is indicated to effect stable long-term, or permanent hair reduction in Fitzpatrick skin types I - VI through

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Attachment 4

selective targeting of melanin in hair follicles (where permanent hair reduction is defined as a long-term stable reduction in number of hairs regrowing after a treatment regimen). The Fotona Dualis® Er:YAG laser is indicated for incision/excision, cutting, ablation, vaporization, and coagulation of soft and hard tissue in various surgical areas.

IV. Summary of Substantial Equivalence

Fotona believes that its Dualis 1 laser system is substantially equivalent to the Fotona Dualis 1 long pulse Nd:YAG laser system previously cleared for incision, ablation, vaporization, and coagulation of soft tissue in various surgical areas, and for permanent hair reduction in Fitzpatrick skin types I - VI, and to the Fotona Fidelis Er:YAG laser system previously cleared for incision/excision, cutting, ablation, vaporization, and coagulation of soft and hard tissue in various surgical areas.

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

The Dualis Nd:YAG/Er:YAG laser system shares the same design features (wavelength, active medium, cooling system, power supply, beam deliveries, controls, housing) as the predicate devices. The output characteristics are the same as those of the predicate devices.

The risk and benefits for the Dualis 9 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 Dualis 80 Nd:YAG/Er:YAG laser system.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Public Health Service

DEC 0 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Fotona D.D Mojca Valjavec OA & RA Manager Stegne 7, 1210 Ljubljana Slovenia

Re: K021548

Trade/Device Name: Fotona Dualis Nd:YAG/Er:YAG Laser System and Accessories Regulation Number: 878.4810 Regulation Name: Instrument, surgical powered laser Regulatory Class: Class II Product Code: GEX Dated: October 18, 2002 Received: October 18, 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

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Page 2 - Sir or Madam

quality systems (QS) 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 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), 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 vours.

Muriam C. Prevost

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

Enclosure

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Hachenuur

Ippendix F:

Indications for Use Statement

510(k) Number (if known): K 021548

Device Name:

Fotona Dualis 50 Nd: YAG/Er: YAG

Indications For

Nd:YAG Laser (1064 nm)

The Fotona Dualis Nd:YAG laser is intended for incision, ablation, vaporization coagulation and hemostasis of vascular lesions and soft tissue in various surgical areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI.

Dermatology: Coagulation and hemostasis of vascular lesions, and 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.

Plastic Surgery: Coagulation and vaporization of soft tissue.

Otonnolaryngology /Head and Neck (ENT): Tissue ablation and vessel hemostasis.

Hemostasis during Surgery: Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscopic) and open procedures.

Orthopedics: Ablation, vaporization, incision, excision, coagulation, and hemostasis of soft and cartilaginous tissue in small and large joints including but not limited to knee menisectomy, knee synovectomy, chondromaliacia and tears, shoulder debridement of scar tissue, and synovectomy of the shoulder.

Neurosurgery: hemostasis in neurosurgery procedures such as excision of brain lesions, spinal cord lesions cranial nerves, peripheral nerves, and pituitary glands.

Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract, cshophageal neoplastic obstructions including squamous cell carcinoma and adenocarcinoma:

Gastrintestinal hemostatsis including varices, espohagitis, esopageat ulcer, Mallory-Weiss tear, gastric ulcer, stomac ulcers, angiodysplasia, non-bleeding ulcers, gastric erosions:

Gastrintestinal tissue ablation including benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, hemorroids.

Er:YAG Laser (2940 nm)

The Fotona Dualis® Er:YAG laser is intended for surgical incision/excision, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, subcutaneous tissue, striated and smooth tissue, cartilage meniscus, muscle, mucous membrane, lymph vessels and nodes, organs and glands.

Dermatology an Plastic Surgery Indications: Epidermal nevi, telangiectasias, spider veins, actinic sheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, decubitis ulcers, and skin resurfacing.

ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia

Gynecology Indications: Herpes simplex, endomaterial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, and condiloma.

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General Surgery Indications: Surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation.

Oral/Maxillofacial Indications: Oral and glossal lesions and gingivectomy

Ophtalmology Indications: Soft tissue surrounding the eye and orbit and anterior capsulotomy

Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae and matrixectomy

Dentistry indications: Caries removal, cavity preparation, enamel etching

(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 General, Restorative and Neurological Devices

Number K021548

Prescription Use (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.