(363 days)
The Quasar Calypso C100 is an Over-The-Counter handheld device intended to emit energy in the red/IR spectrum, specifically indicated for use in the treatment of periorbital wrinkles.
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 periorbital wrinkles.
The Silver Bay, Quasar Calypso, 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 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 Calypso C100 uses a 12 volt wall mount power supply.
The C100 light delivery system used for applying therapy for the use in the treatment of periorbital wrinkles, by emitting at least 65 mW/cm² of red and near infrared (610nm to 850nm) light via an electic 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.
Here's an analysis of the acceptance criteria and study information for the Quasar Calypso C100 Wrinkle Reduction Device based on the provided text:
Important Note: The provided document is a 510(k) summary for a substantial equivalence determination. As such, it focuses on comparing the new device to a predicate device and demonstrating that it does not raise new safety or effectiveness issues. It is not a detailed clinical study report designed to prove efficacy in the same way a PMA (Premarket Approval) submission would. Therefore, many of the requested details about specific clinical study methodologies, such as sample size for the test set, expert qualifications, and adjudication methods, are not present in this type of regulatory document.
Acceptance Criteria and Reported Device Performance
The core of the acceptance criteria for this 510(k) submission is the demonstration of substantial equivalence to a previously cleared predicate device. This means showing that the Quasar Calypso C100 has the same intended use, similar technological characteristics, and does not raise new safety or effectiveness issues compared to the predicate.
Here’s a table summarizing the comparison, which serves as the "performance" data in this context:
| Acceptance Criteria (based on Predicate Device) | Reported Device Performance (Quasar Calypso C100) |
|---|---|
| Intended Use: Treatment of periorbital wrinkles (OTC, handheld, home use) | Same: "The C100 is intended to emit energy in the red and IR region of the spectrum, specifically indicated for use in the treatment of periorbital wrinkles. The target patient population for the C100 is the same as the predicate devices. Like the predicate devices, the C100 is designed for home use." (OTC handheld device) |
| Device Type: Handheld | Same: "Yes" |
| Wavelengths: 605nm, 630nm, 660nm, 855nm | Similar: "610, 630 and 660, 850nm" (Within the specified red and near-infrared range of the predicate: 610nm to 850nm) |
| Modes: On/Off | Same: "On/Off" |
| IR Power Source: LEDs | Same: "LEDs" |
| Visible Light LEDs: Yes | Same: "Yes" |
| Waveform: Constant | Same: "Constant" |
| Energy Source (LEDs/Area): 70 LEDs over 27 sq. cm. | Similar: "40 LEDs. Over 20 sq. cm" (The document notes "performance achieved by these devices is similar with equal power output" despite different LED count and area) |
| Energy Level: 65 mW total | Same: "65 mW total" |
| Power Supply: 115VAC Electric Outlet Power Supply | Same: "115VAC Electric Outlet Power Supply" |
| Treatment Time: 3 minutes daily, min. 5 days/week | Same: "3 minutes daily, minimum 5 days per week" |
| Target Population: Individuals with periorbital lines and wrinkles | Same: "Individuals with periorbital lines and wrinkles." |
| Location for Use: OTC | Same: "OTC" |
| Safety: No new safety issues raised by biocompatibility testing or electrical standards. | Confirmed: Biocompatibility deemed safe (Polycarbonate and ABS plastic, same as predicate). Compliance with IEC/EN 60601-1, IEC/ EN 60601-1-2, IEC 62471 Standards. OSHA/NRTL listed. "The system performs as intended and does not raise any new safety or effectiveness issues." |
Study Information & Limitations
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Sample size used for the test set and the data provenance:
- Not explicitly stated for clinical efficacy. This is a substantial equivalence submission, which primarily relies on technological comparison to a legally marketed predicate. Clinical data proving the efficacy of this specific device for wrinkle reduction is not detailed in this summary. The comparison is based on the predicate's known performance.
- Data Provenance: The document does not describe a new clinical study. The "provenance" is the previous clearance of the predicate device (K101190 - Light for Wrinkles).
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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 / Not explicitly stated. Since a new clinical study with a "test set" and "ground truth" derived from expert consensus for this specific device's efficacy is not described, this information is not provided. The ground truth for the predicate's effectiveness would have been established during its own clearance process.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not stated. No such clinical adjudication method is described for this submission.
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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:
- No. This device is a light therapy system, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant and was not performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device that delivers light therapy, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implicitly from the predicate device's clearance. The "ground truth" for the effectiveness of light therapy for periorbital wrinkles is implicitly accepted through the prior clearance of the predicate device. The current submission demonstrates that the Quasar Calypso C100 operates on the same principles and largely with the same specifications, and therefore should achieve similar outcomes. No specific "ground truth" for this device's efficacy is established in this document.
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The sample size for the training set:
- Not applicable. This section does not describe a machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable. (See point 7).
Summary of the Study/Evidence:
The "study" that proves the device meets the acceptance criteria is primarily a comparison of technological characteristics and intended use to a predicate device (Light for Wrinkles, K101190), alongside demonstrating compliance with relevant electrical safety and biocompatibility standards. The submission asserts that because the Quasar Calypso C100 is substantially equivalent in its design, energy output, wavelengths, and treatment parameters to a legally marketed device with the same intended use, it does not raise new questions of safety or effectiveness. No new large-scale clinical efficacy trials are presented in this 510(k) summary.
§ 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.