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The Quasar C100 Wrinkle Reduction Device is intended to emit energy in the red and IR region of the spectrum, specifically indicated for the treatment of full-face wrinkles.

The Baby Quasar Plus Wrinkle Reduction Device is intended to emit energy in the red and iR region of the spectrum, specifically indicated for the treatment of fullface wrinkles.

The Quasar MD Plus Wrinkle Reduction Device is intended to emit energy in the red and IR region of the spectrum, specifically indicated for the treatment of fullface wrinkles.

The Silver Bay, Quasar C100. Anti-Wrinkle device consists of a collection of red and near infrared diodes (LEDs), packaged in a compact hand held device. The device has a head size of 20 cm² containing the LED array and an on/off switch. The device is made of ABS plastic with clear polycarbonate lenses covering the LED light source. The Quasar C100 uses a 12 volt wall mount power supply. The C100 light delivery system used for applying therapy for the treatment of full-face wrinkles, by emitting at least 65 mWcm² of red and near infrared (610nm to 850nm) light via an electric light emitting diodes [LEDs] energy source. There are 20 red LEDs and 20 infrared LEDs in the head. The device is not intended for ocular applications or direct eye exposure.

The Silver Bay, Baby Quasar Plus Anti-Wrinkle device consists of a collection of red and near infrared diodes (LEDs), packaged in a compact hand held device. The device has a head size of 8.7 cm 2 containing the LED array and an on/off switch. The device is made of anodized aluminum. The Baby Quasar Plus uses a 12 volt wall mount power supply. The Baby Quasar Plus light delivery system used for applying therapy for the use in the treatment of full-face wrinkles, by emitting at least 65 mWcm² of red and near infrared (610nm to 850nm) light via an electric light emitting diodes [LEDs] energy source. There are 12 red LEDs and 12 infrared LEDs in the head. The device is not intended for ocular applications or direct eye exposure.

The Silver Bay, Quasar MD Plus Anti-Wrinkle device consists of a collection of red and near infrared diodes (LEDs), packaged in a compact hand held device. The device has a head size of 15.2 cm 2 containing the LED array and an on/off switch. The device is made of anodized aluminum. The Baby Quasar Plus uses a 12 volt wall mount power supply. The Quasar MD Plus light delivery system used for applying therapy for the use in the treatment of full-face wrinkles, by emitting at least 65 mWcm² of red and near infrared (610nm to 850m), light via an electric light emitting diodes [LEDs] energy source. There are 12 red LEDs and 12 infrared LEDs in the head. The device is not intended for ocular applications or direct eve exposure.

Acceptance Criteria and Device Performance for Quasar Light Therapy Systems

The provided 510(k) summary for the Quasar C100, Baby Quasar Plus, and Quasar MD Plus device (K130225) does not contain specific quantitative acceptance criteria or a detailed study proving the device meets particular benchmarks in terms of clinical efficacy (e.g., a specific percentage reduction in wrinkles, or a statistical significance level for improvement).

Instead, the submission relies on demonstrating substantial equivalence to existing predicate devices (K120775 and K112362) that are already considered safe and effective for their intended use. The "acceptance criteria" in this context are implicitly met by showing that the new devices have similar technological characteristics, indications for use, and a comparable safety profile to the predicates.

Therefore, the table below reflects the comparison of the new devices to the predicate devices, which serves as the "reported device performance" in the context of this 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• No specific clinical "test set" data for efficacy (e.g., wrinkle reduction scores) is presented in this 510(k) summary. The submission relies on establishing substantial equivalence to existing predicate devices.
• The only "study" mentioned relating to user interaction is a Human Factors Study for label comprehension and device use. The document does not provide sample size, data provenance, or specific results for this Human Factors Study beyond the conclusion that the devices were found "adequately safe and effective for the intended users, its intended uses, and use environments." This study would typically assess user interaction and understanding, not clinical efficacy.

3. Number of Experts and Qualifications for Ground Truth

• As there is no specific clinical efficacy study with a "test set" presented, there is no mention of experts used to establish a ground truth for clinical outcomes like wrinkle reduction. The ground truth for the safety and effectiveness of LED light therapy for wrinkles is implicitly established by the FDA's prior clearances of the predicate devices.

4. Adjudication Method for the Test Set

• Since no specific clinical "test set" for efficacy is described, no adjudication method is mentioned for such a test set.

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

• No MRMC comparative effectiveness study was done or reported in this 510(k) summary. This type of study typically assesses the performance of human readers (e.g., radiologists) with and without AI assistance for interpretation tasks, which is not applicable to this light therapy device.

6. Standalone (Algorithm Only) Performance Study

• No standalone (algorithm only) performance study was done or reported. These devices are physical light therapy systems, not algorithms for interpretation.

7. Type of Ground Truth Used

• The "ground truth" for the safety and effectiveness of these devices, in the context of this 510(k), is established by substantial equivalence to existing legally marketed predicate devices. This means that the FDA has previously determined the predicate devices to be safe and effective, and the current submission argues that the new devices are sufficiently similar to warrant the same conclusion.
• For the Human Factors Study, the ground truth would likely be established through observation of user behavior and interviews regarding comprehension of labeling and instructions, but specifics are not provided.

8. Sample Size for the Training Set

• Not applicable. These are physical light therapy devices, not AI/ML algorithms that utilize a "training set" of data in the conventional sense.

9. How Ground Truth for Training Set Was Established

• Not applicable. As there is no AI/ML algorithm with a training set, there is no ground truth established for a training set.

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This is a hand held device intended to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

The Baby Quasar consists of a collection of red and near infrared diodes [LEDs], packaged in a compact handheld device. The device has a head containing the led array, momentary switch, and indicator light.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Baby Quasar Infrared Lamp:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document focuses on demonstrating substantial equivalence to a predicate device rather than setting specific quantitative acceptance criteria or reporting detailed clinical performance metrics like wrinkle reduction percentages or photographic evidence. The "reported device performance" is largely framed by its similarity to the predicate device.

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

The provided document does not mention any clinical test set involving human subjects for evaluating the effectiveness of the Baby Quasar device. The testing described primarily covers functional performance, electrical safety, and EMC of the device itself.

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

As there's no mention of a clinical test set with human subjects, there's no information about experts used to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set using human subjects is described.

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 device is an infrared lamp for wrinkle reduction, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI-related metrics are relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

For the device's functional and safety testing, the ground truth would be based on established engineering and safety standards (e.g., power level specifications, electrical safety criteria, EMC standards).

For the intended effect (wrinkle reduction), the document states an equivalence to predicate devices, which would have historically demonstrated effectiveness. However, no specific clinical ground truth (e.g., expert consensus on wrinkle severity, photographic analysis) is described for the Baby Quasar itself in this submission.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product that utilizes a training set.

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

Not applicable, as there is no training set mentioned.

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