Search Results

The Deka Synchro FT is indicated for the following treatments:

Nd: YAG laser: Removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to warts, teleangiectasia, leg veins and spider veins, treatment of benign pigmented lesions.

Pulsed light attachment: Permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions.

Different wavelength ranges of Pulsed Light attachment are indicated for the various treatments and skin types, as indicated in the following table:

| Pulsed light

The Deka Synchro FT is a platform which can be equipped with an internal hi-power long pulse Nd:YAG laser module and a pulsed light handpiece (FT handpiece). SynchroFT with the long pulse Nd:YAG module comes with a wide range of interchangeable, quick release handpieces with electronic spot recognition. The FT handpiece is equipped with five different emission spectra interchangeable filters. The system allows to switch from one of the two available sources to the other by pressing a key on keyboard. Handpiece activation is either by footswitch or fingerswitch.

Overall weight of the device is 65 kg, and the size is 100 cm x 50 cm x 83 cm (H x W x D).

Electrical requirement is 230VAC, 16A, 50-60 Hz, single phase.

The provided 510(k) summary for the Deka Synchro FT device does not include any acceptance criteria or a study demonstrating the device meets such criteria.

Instead, the submission relies on substantial equivalence to predicate devices (El.En. Synchro HP Platform and El.En. Minisilk FT) for its approval. This means that the device's safety and effectiveness are asserted to be similar to those of devices already legally marketed, rather than being proven through new performance data against specific acceptance criteria.

Therefore, most of the information requested in your prompt regarding acceptance criteria and a study to prove device performance cannot be extracted from this document.

Here's a breakdown of what can be stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

No test set was used for a performance study. The submission explicitly states:

• Nonclinical Performance Data: None
• Clinical Performance Data: None

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

Not applicable, as no test set or clinical performance data was provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no test set or clinical performance data was provided.

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 and pulsed light system, not an AI-assisted diagnostic or interpretation tool. No MRMC study was conducted.

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

Not applicable. This device is a physical medical device (laser/pulsed light system), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable, as no performance study was conducted requiring ground truth establishment.

8. The sample size for the training set

Not applicable, as no training set was used for an algorithm.

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

Not applicable, as no training set was used for an algorithm.

Summary of Device Approval Approach:

The Deka Synchro FT device gained 510(k) clearance based on its substantial equivalence to previously cleared predicate devices (El.En. Synchro HP Platform for Nd:YAG laser aspects and El.En. Minisilk FT for pulsed light attachment). The manufacturer states that the Deka Synchro FT has the same indications for use, principle of operation, and "essentially the same performances" as these predicate devices. No new nonclinical or clinical performance data were submitted to demonstrate safety or effectiveness by meeting specific acceptance criteria for this new device.

Ask a specific question about this device