(96 days)
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."
§ 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.