(163 days)
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
| Feature | Predicate Device (Light for Wrinkles - K120775) | Predicate Device (C100 - K112362) | Submitted Devices (C100, Baby Quasar Plus, Quasar MD Plus - K130225) | "Acceptance Criteria" (Substantial Equivalence) |
|---|---|---|---|---|
| Indications for Use | Treatment of full-face wrinkles. | Treatment of periorbital wrinkles. | Treatment of full-face wrinkles. | Consistent or comparable indications. (The C100 from K112362 had periorbital, but the submitted C100 and other devices match K120775 for full-face.) |
| Handheld | Yes | Yes | Yes | Yes |
| Wavelengths | 605nm, 630nm, 660nm, 855nm | 610, 630, 660, 850nm | 610, 630, 660, 850nm | Similar red and near-infrared spectrum. |
| Modes | On/Off | On/Off | On/Off | Simple operation. |
| IR Power Source | LEDs | LEDs | LEDs | Same technology. |
| Visible Light LEDs | Yes | Yes | Yes | Presence of visible light LEDs. |
| Waveform | Constant | Constant | Constant | Constant waveform. |
| Energy Source | 70 LEDs over 27 sq. cm. | 40 LEDs over 20 sq. cm. | C100: 40 LEDs over 20 sq. cm. | |
| Baby Quasar Plus: 24 LEDs over 8.7 sq. cm. | ||||
| Quasar MD Plus: 24 LEDs over 15.2 sq. cm. | Comparable LED count and coverage area for intended use. | |||
| Energy Level | 65 mW total | 65 mW total | 65 mW total | Comparable radiant power output. |
| Power Supply | 115VAC Electric Outlet Power Supply | 115VAC Electric Outlet Power Supply | 115VAC Electric Outlet Power Supply | Standard electrical power. |
| Treatment Time | 3 minutes daily, minimum 5 days per week | 3 minutes daily, minimum 5 days per week | 3 minutes daily, minimum 5 days per week | Consistent treatment regimen. |
| Target Population | Individuals with facial lines and wrinkles. | Individuals with periorbital lines and wrinkles. | Individuals with facial lines and wrinkles. | Comparable target population. |
| Location for Use | OTC | OTC | OTC | Over-the-counter use. |
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.
§ 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.