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The Omnilux Revive and Blue 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 Omnilux Revive and Blue is a combination of two sources of high spectral purity. They provide uniform or "hot-spot" headwidth. The output pre-tuned to one wavelength with a narcow spectral bandwidth: Rlue is 415 + 2 wavelength of Omnilux Revive is 63 + 5 mm, and Omnilux Blue is 415 + 5m. The Omnilux base unit contains the III I FD hose same attached to the end of the arms and then positioned for patient to the lesting. The user interface an LCD and keyboard together with the control devices functions an LCD and Reyboard together while the reasonal control all device functions.

This 510(k) summary does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a definitive study proving the device meets those criteria. The document explicitly states:

"Based upon an analysis of the overall performance characteristics for the device, Photo Therapeutics Limited believes that no significant differences exist between Photo Therapeutics Eamined an' and the previously approved the Onlinex Revive (K030426) and Omnilux Blue (K030883) devices and their Omnilux Revive (R050+20) and Onlines Revive and Blue Combination raises no new issues of safety or effectiveness."

This statement indicates that the submission relies on the substantial equivalence to previously approved devices (Omnilux Revive and Omnilux Blue), rather than presenting a new, dedicated clinical study with defined acceptance criteria for the combination device. Therefore, a table of acceptance criteria and the performance of this specific combination device against those criteria is not provided in this document.

However, I can extract the available information and indicate where details are not present:

Here's a breakdown of the information provided, or where it's absent:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of acceptance criteria or performance metrics for the Omnilux Revive and Blue Combination device in the context of a new study designed for this specific combination. Instead, it asserts substantial equivalence to previously approved Omnilux Revive and Omnilux Blue devices. Therefore, the "reported device performance" for this combination is inferred to be similar to its predicate devices for their respective indications.

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

• Sample Size: Not applicable/not stated. The document doesn't detail a new clinical test set for the Omnilux Revive and Blue Combination. It relies on the performance characteristics of its predicate devices.
• Data Provenance: Not applicable/not stated for a new study. The predicate devices were likely approved based on data (country of origin, retrospective/prospective) from their respective submissions (K030426 and K030883), but those details are not provided here for reference.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable/not stated, as no new test set is described for this combination device.

4. Adjudication Method for the Test Set:

• Not applicable/not stated, as no new test set is described for this combination device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study is not mentioned or implied for the Omnilux Revive and Blue Combination device. The submission focuses on substantial equivalence.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This is a light therapy device, not an AI or algorithm-based diagnostic tool. "Standalone performance" in this context would refer to the device's physical output and direct therapeutic effect, not an algorithmic assessment.

7. The Type of Ground Truth Used:

• Not applicable/not stated for a new study. For the predicate devices, "ground truth" for acne treatment would typically be clinical assessment by dermatologists, possibly using standardized photographic scales or lesion counts. However, this is not detailed for the combination device here.

8. The Sample Size for the Training Set:

• Not applicable/not stated, as this is not an AI/machine learning device that involves a "training set."

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

• Not applicable/not stated, as this is not an AI/machine learning device.

Summary of Device and Indication:

• Device Name: Omnilux Revive and Blue Combination
• Indication for Use: "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."
• Mechanism: Combines two sources of high spectral purity light:
  • Omnilux Revive: Wavelength of 633 ± 5 nm (red light)
  • Omnilux Blue: Wavelength of 415 ± 5 nm (blue light)
• Basis for Approval: Substantial equivalence to previously approved Omnilux Revive (K030426) and Omnilux Blue (K030883) devices. The manufacturer asserts that "no significant differences exist" and that "the Omnilux Revive and Blue Combination raises no new issues of safety or effectiveness."

To find detailed performance data and acceptance criteria, one would need to review the 510(k) submissions for the individual predicate devices: K030426 (Omnilux Revive) and K030883 (Omnilux Blue).

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The Profile BBL (and the light and/or laser delivery accessories) is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.
It is intended for use for:
• The treatment of tattoos;
• The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
• The treatment of cutaneous lesions including warts, scars and striae;
• The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, engiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
• Treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis; and
• The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction.
The integral thermo-electric cooler is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
• Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
• Reduce discomfort during and/or associated with light or laser treatment:
• Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;
• Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and
• Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

Profile BBL System emits intense wide spectrum emission with wavelength of 500-1400 nm. It consists of a system console, internal computer, control panel and display, and a treatment head comprised of a light guide with cooling capability and a pushbutton switch.

The provided text is a 510(k) summary for the Sciton Profile BBL System. It establishes substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

This document focuses on the regulatory aspects of device clearance, asserting equivalence based on similar indications for use, design features, and functional features compared to previously cleared devices. It does not present novel performance data or detail any studies designed to meet specific acceptance criteria for the Sciton Profile BBL System itself.

Therefore, the requested information, such as a table of acceptance criteria and device performance, sample sizes, expert qualifications, ground truth details, or MRMC study results, cannot be extracted from the provided text.

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The SpectraPulse system is indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (facial and leg veins), benign pigmented lesions in skin types I-IV according to the Fitzpatrick scale.

The Spectrapulse® pulsed light system is intended for photothermolysis of blood vessels (facial and leg veins), photocoagulation of dermatological vascular lesions, and the treatment of benign pigmented lesions for skin types I - IV according to the Fitzpatrick scale.

The SpectraPulse system is a light-based medical device designed for treatment of vascular lesions (fascial and leg) and benign pigmented lesions.

The provided text does not contain information about specific acceptance criteria, study details proving device performance against those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies.

Instead, the document is a 510(k) summary for the SpectraPulse® pulsed light device. Its primary purpose is to establish substantial equivalence to a legally marketed predicate device (Palomar Medical Technologies, Inc. EsteLux TM, K020453) rather than to present detailed performance study data against pre-defined acceptance criteria.

The "Performance Data" section in the summary is conspicuously empty, followed by a "Conclusion" that states: "The differences in specifications of the Spectrapulse® and the predicate device do not result in different performance or raise new questions of safety or efficacy. Based on the foregoing, the SpectraPulse system is substantially equivalent to the legally-marketed predicate device."

Therefore, I cannot populate the requested table or answer most of your detailed questions based on the provided text.

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