(483 days)
The LIGHTWAVE Deluxe Red light is indicated for use in dermatology for treatment of superficial; benign vascular, and pigmented lesions.
The LIGHTWAVE Deluxe Red and Blue light combination is intended to emit energy in the red and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
THE LIGHTWAVE Deluxe Blue light is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
THE LIGHTWAVE Deluxe Red and Blue light combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
THE LIGHTWAVE Deluxe Infrared Light is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
The LIGHTWAVE™ Professional Deluxe System uses high-end Light Emitting Diodes (LED's) to distribute the specific wavelengths of light it uses. This technology is commonly referred to as Photobiostimulation, Light Emitting Diode Therapy (LEDT), LLLT, or LED's. The application of LED's to tissue is non-invasive. These devices are solid state and hand free mounted for placement directly over the skin where the treatment is to occur.
The LIGHTWAVE Professional Deluxe LED system is a combination of two sources of high chromatic accuracy. They provide uniform even coverage exposure area. The output wavelengths of LIGHTWAVE Professional Deluxe Range from 630 nm (visible red) to 830nm (near infrared). The LIGHTWAVE Professional Deluxe base unit contains the power supplies and the control unit. The LED panel can be configured to contain one (1), two (2) or three (3) row(s) of LED (600, 1200 or 1800 LEDs respectively) based on system configuration. The LED panel is attached to the end of the arms and then positioned for patient treatment. The control unit consists of an LCD and keyboard together with the control electronics. The user interface software allows the operator to access and control all device functions.
Here's an analysis of the provided text regarding the LIGHTWAVE Professional Deluxe device.
Important Note: The provided document is a 510(k) summary for a medical device. It explicitly states that formal clinical trials were not deemed necessary because the device uses the same technology and intended use as predicate devices. Therefore, the information you requested about "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, etc., is largely not present in this document. The "proof" here is based on substantial equivalence to existing devices.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence: The device's intended use and major performance parameters are similar or equivalent to predicate devices (Photo Therapeutics Ltd. K030883, Omnilux Revive (K030426), Omnilux Plus (K043317), Omnilux Revive and Plus Combination (K050216)). | The LIGHTWAVE Professional Deluxe has an "intended use and major performance parameters (energy transmission levels and wavelength)" that are deemed "similar or equivalent to the same characteristics of the Photo Therapeutics Omnilux devices." The output wavelengths range from 630 nm (visible red) to 830nm (near infrared). |
| Safety and Effectiveness: Demonstrated through compliance with recognized standards. | Testing conducted in accordance with IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for safety) and IEC 60601-1-2:2001 (Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests). |
| Indicated Uses: The device must meet the performance for its specified indications. | - Red light: Indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions. |
- Red and Blue light combination: Intended to emit energy in the red and blue region to treat mild to moderate acne vulgaris.
- Blue light: Indicated to treat moderate inflammatory acne vulgaris.
- Red and Infra-red light combination: Intended to emit energy in the red and infra-red region for the treatment of periorbital wrinkles.
- Infrared Light: Intended to emit energy in the IR spectrum to provide topical heating for temporary relief of minor muscle/joint pain, arthritis, muscle spasm; relieving stiffness; promoting muscle relaxation; and temporarily increasing local blood circulation. |
Study Details (Based on the provided document)
Since formal clinical trials for this specific device were not conducted, much of the requested information regarding study specifics is not applicable. The primary "study" supporting its market clearance is the comparison to predicate devices and compliance with safety standards.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. No clinical test set (patient data) was used for performance evaluation of this specific device. Performance was established by comparison to predicate devices.
- Data Provenance: Not applicable. No patient data from a specific country or retrospective/prospective study was used for this device's performance evaluation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth based on expert review of a test set was established for this device's performance given the lack of clinical trials. The FDA review process itself involves experts within the agency assessing substantial equivalence.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication was used.
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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 light therapy system, not an AI-assisted diagnostic or imaging device. No MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm-only device. Its performance is related to its physical properties (wavelengths, energy output) and its intended therapeutic effects when applied by a human operator.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the safety and effectiveness claim of this device is primarily substantial equivalence to legally marketed predicate devices whose safety and effectiveness for similar indications have already been established, coupled with compliance with recognized electrical and medical device safety standards (IEC 60601-1 and IEC 60601-1-2:2001). There is no "ground truth" derived from patient-specific data for this device.
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The sample size for the training set:
- Not applicable. No training set was used as this device does not involve machine learning or AI algorithms in its performance evaluation.
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How the ground truth for the training set was established:
- Not applicable. No training set was used.
§ 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.