Search Results

Alexandrite 755nm laser source:
Temporary hair reduction.
Stable long-term or permanent hair reduction through selective targeting of
melanin in hair follicles. Permanent hair reduction is defined as the long-term,
stable reduction in the number of hairs regrowing when measured at 6,9, and 12 months after the completion of a
treatment regime, on all skin types (Fitzpatrick I - VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
Photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
Nd:YAG 1064nm laser source:
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB . The lasers are indicated on all Skin Types Fitzpatrick I-VI including tanned skin.
Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as but not limited to port wine stains, hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue.
Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.
The laser is indicated for benign pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.

Motus AZ is a medical device equipped with Alexandrite 755nm laser and Nd: YAG 1064nm laser.
The laser sources deliver the laser output through a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition.
The modifications to the device consist on a restyling of the device (chassis, cover plastics and GUI) and on modifications to Moveo handpiece (new spot sizes available and new optional spacer). The spot size and the fluences are within the range of the already cleared device (K181486). The optional spacer is made of a biocompatible material (Anticorodal 6082), already used in previously cleared devices for the same type of contact (K192539, K172362, K172362, K133895).
The intended use of the modified devices, as described in the labelling, has not changed as a result of the modifications. Labelling itself has been updated also to include general improvements that have been implemented since predicate device clearance and considered as minor changes.

This document is a 510(k) summary for the DEKA Motus AZ device, a laser surgical instrument. It primarily focuses on demonstrating substantial equivalence to a predicate device (DEKA Motus AY, K181486) rather than providing extensive details about a specific clinical study for performance acceptance criteria.

The acceptance criteria presented are essentially that the proposed device (DEKA Motus AZ) maintains the same or equivalent specifications and performance characteristics as the predicate device (DEKA Motus AY). The submission asserts that the modifications are minor and do not affect safety or effectiveness.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria for clinical efficacy or specific performance metrics in the way one might expect from a clinical trial summary. Instead, the acceptance criteria are implicitly met by demonstrating that the DEKA Motus AZ's specifications and performance are identical to or within acceptable variations of the predicate device (DEKA Motus AY).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily relies on demonstrating substantial equivalence to a predicate device through engineering and performance comparisons, not on a prospective clinical trial with a "test set" as one might find for a novel device or AI algorithm. It's a "Special 510(k)" which generally indicates modifications to an already cleared device.

Therefore, there is no mention of a specific clinical "test set" sample size or data provenance in the context of efficacy for the modified DEKA Motus AZ device. The "data" refers to engineering and non-clinical performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This submission is for a laser surgical instrument, and the performance testing mentioned (electrical safety, EMC, software validation) does not involve establishing ground truth by medical experts for image interpretation or diagnosis.

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

Not applicable. See #3.

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 is a laser surgical instrument, not an AI-based diagnostic tool that would typically involve MRMC studies or human reader improvement with AI assistance.

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

Not applicable. See #5.

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

Not applicable in the context of clinical efficacy ground truth for a test set. The "ground truth" for this submission are the established safety and performance standards for laser medical devices and the characteristics of the predicate device.

8. The sample size for the training set

Not applicable. This document does not describe the development or testing of an AI algorithm with a training set.

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

Not applicable. See #8.

Summary of the Study Proving Acceptance Criteria:

The "study" proving the device meets its acceptance criteria, in this context, is the demonstration of substantial equivalence to the predicate device (DEKA Motus AY, K181486) through a combination of:

• Non-clinical performance testing:
  • Electrical safety and electromagnetic compatibility (EMC): Conducted according to ANSI AAMI ES60601-1 and IEC 60601-1-2 standards.
  • Software Validation and Verification Testing: Conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
  • Additional non-clinical testing: Conducted according to IEC 60601-2-22 (particular requirements for laser equipment) and IEC 60825-1 (safety of laser products).
• Comparison of technological characteristics: A detailed side-by-side comparison (as shown in the provided table) confirming that the proposed device (DEKA Motus AZ) shares the same intended use, fundamental technology (Alexandrite 755nm and Nd:YAG 1064nm lasers, wavelengths, fluences, pulse durations, repetition rates, skin cooling systems), and similar or identical essential design parameters within acceptable ranges as the predicate device. The changes (restyling, new Moveo handpiece spot sizes and optional spacer) were evaluated to ensure they do not introduce new questions of safety or effectiveness.

The conclusion states: "Based on the comparison of indications for use and the technological characteristics, we can conclude that DEKA Motus AZ is as safe, as effective, and performs as well as the legally marketed predicate device (K181486)." This statement serves as the proof that the device meets the implicit acceptance criteria of being substantially equivalent to the cleared predicate.

Ask a specific question about this device

ERISE Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectas; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars). With microbeam end piece it is indicated for Skin resurfacing.

ERISE is an Erbium:YAG laser handpiece delivering laser radiation at 2940nm. It is intended to be used with DEKA LUXEA platform, cleared by FDA with K192539. The Erise laser handpiece includes: - . A connector to connect to the console - A cord where electrical cables and hydraulic tubes pass in - A plastic shell - . A Laser cavity - . A mechanical shutter - . An optical guide - . An ending tip which provides different spot sizes (diameter 2, 4, 9mm), including microbeam output (diameter 9mm) The 2940 nm Erbium:YAG laser handpiece is controlled by the DEKA LUXEA console which it is connected to, through the connector.

The provided FDA 510(k) summary for the ERISE Laser Handpiece does not contain information about acceptance criteria for a device performance study or any study proving such criteria are met.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Quanta System 2940 nm Er:YAG laser handpiece) based on technological characteristics and non-clinical performance data.

Here's a breakdown of why the requested information cannot be provided from this document:

1. No Clinical Performance Data: The document explicitly states under "Clinical Performance Data:" "None". This means no studies were conducted to evaluate the device's clinical effectiveness in terms of specific outcomes or meeting pre-defined acceptance criteria for efficacy.

2. Focus on Substantial Equivalence: The primary goal of a 510(k) submission is to show that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological features, safety standards, and non-clinical performance, rather than conducting new clinical trials with acceptance criteria.

3. Non-Clinical Data for Safety and Compatibility: The "Non-Clinical Performance Data" section describes tests related to:

   • Safety and electromagnetic compatibility (EMC): Compliance with standards like IEC 60601-2-22, IEC 60825-1 (for safety) and IEC 60601-1-2 (for EMC) for the DEKA LUXEA platform (which the ERISE handpiece connects to). These are regulatory compliance tests, not performance studies with acceptance criteria for specific clinical outcomes.
   • Software Verification and Validation: This ensures the software of the DEKA LUXEA platform (with the ERISE handpiece) functions as intended. Again, this is a form of regulatory compliance and quality assurance, not a performance study evaluating clinical efficacy.

Therefore, it is not possible to complete the requested table or answer the specific questions about acceptance criteria and performance studies because such information is not present in this 510(k) submission. The device's approval is based on its similarity to an already cleared device and adherence to relevant safety and software standards, not on new clinical performance data demonstrating specific efficacy outcomes against predefined acceptance criteria.

Ask a specific question about this device