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The intense pulsed light therapy system is indicated for use in surgical, aesthetic and cosmetic application in the hair removal at a wavelength ranging from 690-1200nm.

The IPL Therapy Systems is an Intense Pulsed Light Therapy System which delivers intense pulsed light at a wavelength ranging from 690nm -1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective photothermolysis. That is causing thermal damage to target chromophores by using light of appropriated wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin. IPL Therapy System is different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores. The Sincoheren IPL Therapy system controlled by computer is composed: - Main unit - LCD monitor - Treatment handle . The embedded microprocessor monitors can control the system continually. The operating Interface includes a full-LCD screen (8.0 inch), the key switch and emergency shut-off knob. LCD screen both shows the system work program, treatment parameters and number of light emitting. The treatment handle operated by hand comprises the intense emitter and transmission system.

The provided document is a 510(k) summary for an Intense Pulsed Light Therapy System. It states that no clinical studies were required to support substantial equivalence. Therefore, it does not contain the information needed to answer many of the questions regarding acceptance criteria, study details, and performance.

However, based on the information provided, here's what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria or reported device performance metrics are provided in this 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from clinical trials.

The "Indications for Use" section (page 6) does list "Density" (energy density in J/cm²) and "Program" settings for hair removal across different skin types (I-V, with N/A for VI). However, these are operational parameters, not performance metrics or acceptance criteria.

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

Not applicable. No clinical test set was used for this submission. The device did not require clinical studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No clinical studies were performed, and thus no ground truth was established by experts for a test set.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No clinical studies were done, so no MRMC study with or without AI assistance was performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Not applicable. This device is a medical device (IPL system) operated by a human, not an AI algorithm. Its performance is tied to the operator and the device's physical parameters.

7. Type of Ground Truth Used

Not applicable. No clinical studies were performed. The "ground truth" for this 510(k) submission primarily relies on the equivalency of its non-clinical specifications and intended use to a legally marketed predicate device.

8. Sample Size for the Training Set

Not applicable. This is a hardware medical device; it does not involve machine learning or a "training set" in the computational sense. The "development" aspects mentioned (Risk Analysis, Requirements Reviews, Design Reviews, etc.) refer to engineering and quality assurance processes, not AI model training.

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

Not applicable. As above, there is no training set for this type of device.

Summary of Device's Basis for Approval (from the document):

The device's approval is based on:

• Substantial Equivalence: The manufacturer asserts that the Intense Pulsed Light Therapy System is "as safe, as effective, and performance is substantially equivalent to the predicate device(s)" (K093627 IPLUSELIGHT IPL SYSTEM).
• Non-Clinical Tests: Compliance with voluntary standards (IEC 60601-1, IEC 60601-1-2) and internal quality assurance measures (Risk Analysis, Requirements Reviews, Design Reviews, raw materials verification, unit/module verification, integration testing, final acceptance testing, performance testing, safety testing).
• No Clinical Studies Required: "The subject of this premarket submission, Intense Pulsed Light Therapy System, did not require clinical studies to support substantial equivalence."

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The IPL Therapy Systems (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications in the hair removal at a wavelength ranging from 640nm-1200nm.

The IPL Therapy Systems (ST-AI) is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 640nm-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective photothermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin. IPL Therapy system is different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores. Based on this, the IPL Therapy Systems (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications in the hair removal.

This document describes an "IPL Therapy System" (ST-AI) and its substantial equivalence to predicate devices, focusing on its use for hair removal. However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria, nor does it include performance data, sample sizes, expert qualifications, or details about ground truth.

The document is a 510(k) summary for a medical device and primarily focuses on:

• Identification of the device and sponsor.
• Device description: An intense pulsed light (IPL) system working on selective photothermolysis for hair removal.
• Intended use: Surgical, aesthetic, and cosmetic applications in hair removal.
• Compliance with standards: IEC 60601-1 and IEC 60601-1-2.
• Substantial Equivalence (SE) determination: The FDA determined the device is substantially equivalent to existing legally marketed devices (K091664 and K083915). This determination is based on the claim that the device is safe and effective because it is substantially equivalent to predicates, not through direct performance studies presented in this summary.

Therefore, I cannot fulfill your request for: Acceptance criteria table, reported device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC study details, standalone performance, type of ground truth, training set size, or how ground truth for the training set was established.

This information would typically be found in detailed clinical or performance studies, which are not part of the provided 510(k) summary. The summary only attests that the device is designed, tested, and will be manufactured in accordance with specified safety standards and that it's substantially equivalent to predicate devices for its intended hair removal use.

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