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.

Device Description

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.

AI/ML Overview

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

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).
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.
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.
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.
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.
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.
The sample size for the training set:
- Not applicable. This section does not describe a machine learning algorithm that requires a "training set."
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.

Summary

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K112362 P. 1 of 9

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AUG 1 4 2012

510(k) Summary

This summary of 510(k) summary information is being submitted in accordance with the requirements of 21 CFR § 878.4810.

Submission Date: August 1, 2011

Submitter Information:

AEGIS Regulatory, Inc. - Robert T. Wagner 1131 Anthem View Lane Knoxville, TN 37922 Tel.: 865-982-5552 Email: bob@fdalistingconsultants.com Silver Bay, LLC d/b/a Quasar Bio-Technologies Attn: Peter Nesbitt 1431 Tallevast Rd. Sarasota, FL 34231 Tel.: 941-306-5812 Email: peter@quasarbiotech.com

For Manufacturer:

General Information

2.1 Classification Name: Wrinkle Reduction Device

2.2 Common/Usual Name: Light Therapy System, Quasar Calypso C100

2.3 Proprietary Names: Quasar Calypso C100 Wrinkle Reduction Device

2.4 Classification: Class II

2.5 Classification Number: 878.4810

2.6 Product Codes: OHS

3. Device Description:

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.

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K112362. p. 2.0+5

4. Indications / Intended Use:

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.

Rx or OTC:

The C100 is an Over the Counter (OTC) device. The labeling, instructions, and User Operations (21 CFR § 801.60 and 61), are designed for layman understanding and use. The predicate device is OTC.

5. Predicate Device:

This device is substantially equivalent to the following predicate devices, which are currently in safe and effective commerce:

K101190 - Light for Wrinkles (Led Intellectual Properties, LLC)

Predicate Chart

Device	Light for Wrinkles	C100
	AAL OCT (K101190)LED IntellectualProperties LLC	Quasar Bio-Tech Inc
	Properties LLC	K112362
	A Predicate Device	This Submission
Indications	The Light for Wrinklesis an Over-The-Counterhandheld deviceintended for use in thetreatment ofperiorbital wrinkles.The target patientpopulation for the AALOCT is persons withperiorbital wrinkles. Itis designed for homeuse.	The C100 is intendedto emit energy in thered and IR region ofthe spectrum,specifically indicatedfor use in thetreatment ofperiorbital wrinkles.The target patientpopulation for theC100 is the same as thepredicate devices. Likethe predicate devices,the C100 is designed
Device	Light for Wrinkles	C100
	AAL OCT (K101190)LED IntellectualProperties LLC	Quasar Bio-Tech IncK112362
	A Predicate Device	This Submission
		for home use.
Handheld	Yes	Yes
Wavelengths	605nm, 630nm,660nm, 855nm	610, 630 and 660,850nm
Modes	On/Off	On/Off
IR powersource	LEDs	LEDs
Visible lightLEDs	Yes	Yes
Waveform	Constant	Constant
EnergySource	70 LED's over 27 sq.cm.	40 LEDs. Over 20 sq.cm
EnergyLevel	65 mW total	65 mW total
PowerSupply	115VAC Electric OutletPower Supply	115VAC Electric OutletPower Supply
TreatmentTime	3 minutes daily,minimum 5 days perweek	3 minutes daily,minimum 5 days perweek
TargetPopulation	Individuals withperiorbital lines andwrinkles.	Individuals withperiorbital lines andwrinkles.
Location forUse	OTC	OTC

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Summary of the technological characteristics of the device compared to predicate device:

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The C100 and the above referenced predicate. Light for Wrinkles device, are Over the Counter Devices used to treat wrinkles as defined in 21 CFR § 878.4810. These devices utilize red and infrared diodes from 610 to 850 nm to provide narrow bands of light energy to treat wrinkles. The performance achieved by these devices is similar with equal power output. The devices are handheld, and intended to be placed directly on the skin or held just over the skin. They are manufactured out of similar materials. Based upon comparison to the predicate device, the C100 has the same intended uses, with similar technological characteristics as the predicate device. The system performs as intended and does not raise any new safety or effectiveness issues.

6. Biocompatibility:

The only patient contact material in the C100 is the light head and body of the device.

The light head in contact with the face is Polycarbonate and the body is constructed of ABS plastic. the same materials used in the predicate device. The biocompatibility of these materials are well known and considered safe when in contact with heatthy skin. A review of the Biocompatibility decision is shown on the "General Program Memorandum- #G95-1. Attachment C, Biocompatibility Flow Chart for the Selection of Toxicity Tests for 510(k)s."

The conclusion is that the C100 m does not raise any new safety issues.

7. Performance Testing and Standards:

These devices have been tested under and are in compliance with performance standards that have been established for such devices under Section 878 of the Federal Food, Drug, and Cosmetics Act. All electrical and radiological products made by the applicant have been OSHA/NRTL listed, and have received constituent marks.

The device has been tested and is in conformity with IEC/EN 60601-1, IEC/ EN 60601-1-2, IEC 62471 Standards.

8. Statement of Safety and Effectiveness:

The information in this 510(k) submission was used to support the safety and effectiveness of this device with respect to its cited predicates.

9. Substantial Equivalence Discussion

After an analysis of the safety, indications, intended uses,

performance, features, design materials, power output, technological properties, treatment areas, treatment regimes and methods of operation, the manufacturer believes that no

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significant differences exist between the device and the predicates listed in Section 5 Therefore substantial equivalency is requested.

K112362 2.5

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's symbol, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Silver Bay, LLC % Aegis Regulatory, Incorporated Mr. Robert T. Wagner CEO 1131 Anthem View Lane Knoxville, Tennessee 37922

AUG 1 4 2012

Re: K112362

Trade/Device Name: Quasar C100 Wrinkle Reduction Device Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: OHS Dated: August 13, 2012 Received: August 13, 2012

Dear Mr. Wagner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. Robert T. Wagner

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Millman

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ki12362

INDICATIONS FOR USE STATEMENT

510(k) Number: K112362

Device Name: Quasar C100 Wrinkle Reduction Device

Indications for Use:

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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)

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Division of Surgical, Orthopedic,
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K112362

510(k) Number

Silver Bay LLC Quasar C100

Premarket Notification

Regulation Number and Section

§ 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.