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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.

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.

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.

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