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.

Device Description

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.

AI/ML Overview

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.

Summary

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510(k) Summary

K130225

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

Submission Date: January 15, 2013

1. Submitter Information:	AEGIS Regulatory, Inc. - Robert T. Wagner
	2424 Dempster Drive
	Coralville, IA 52241
	Tel.: 865-982-5552
	Email: bob@fdalistingconsultants.com
For Manufacturer:	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

2. General Information

2.1
2.2 Common/Usual Name: Light Therapy System, Quasar C100, Baby Quasar Plus, Quasar

MD Plus

2.3 Proprietary Names: Quasar Calypso C100 Wrinkle Reduction Device, Baby Quasar Plus,

Quasar MD Plus

2.4 Classification: Class II
2.5 Classification Number: 878.4810
2.6 Product Codes: OHS

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3. Device Description:

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 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 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.

4. Indications / Intended Use:

The Quasar 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 full-face wrinkles.

The Baby Quasar Plus is an Over-The-Counter handheld device intended to emit energy in the red/IR spectrum, specifically indicated for use in the treatment of full-face wrinkles.

The Quasar MD Plus is an Over-The-Counter handheld device intended to emit energy in the red/IR spectrum, specifically indicated for use in the treatment of full-face wrinkles

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Rx or OTC:

he C100, Baby Quasar Plus, and Quasar MD Plus are Over the Counter . The labeling, instructions, and

Predicate Device ખં

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

K120775 Light for Wrinkles (Led Intellectual Properties, LLC : し
K112362 Quasar C100 Anti-Wrinkle Device (Quasar Bio-Tech Inc ਪ

Predicate Cha

Device
Light for WrinklesAAL OCT (K120775)LED IntellectualProperties LLC	C100Quasar Bio-Tech IncK112362A Predicate Device	C100Quasar Bio-Tech IncKXXXXXXThis Submission	Baby Quasar PlusQuasar Bio-Tech IncKXXXXXXThis Submission	Quasar MD PlusQuasar Bio-Tech IncKXXXXXXThis Submission
Indications	The Light for Wrinkles isan Over-The-Counterhandheld deviceintended for use in thetreatment of full-facewrinkles. The targetpatient population forthe AAL OCT is personswith facial wrinkles. Itis designed for homeuse.	The C100 is intended toemit energy in the redand IR region of thespectrum, specificallyindicated for use in thetreatment of periorbitalwrinkles. The targetpatient population for theC100 is periorbitalwrinkles. The C100 isdesigned for home use.	The C100 is intended toemit energy in the redand IR region of thespectrum, specificallyindicated for use in thetreatment of full-facewrinkles. The target	The Baby Quasar Plus isintended to emit energy inthe red and IR region ofthe spectrum, specificallyindicated for use in thetreatment of full-facewrinkles. The targetpatient population for theBaby Quasar Plus is thesame as the predicatedevices. Like thepredicate devices, theBaby Quasar Plus isdesigned for home use.	The Quasar MD Plus isintended to emit energy inthe red and IR region ofthe spectrum, specificallyindicated for use in thetreatment of full-facewrinkles. The targetpatient population for theQuasar MD Plus is thesame as the predicatedevices. Like the predicatedevices, the Quasar MDPlus is designed for homeuse.

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Device	Light for WrinklesAAL OCT (K120775)LED IntellectualProperties LLC	C100Quasar Bio-Tech Inc	C100Quasar Bio-Tech Inc	Baby Quasar PlusQuasar Bio-Tech Inc	Quasar MD PlusQuasar Bio-Tech Inc
	A Predicate Device	K112362	KXXXXXX	KXXXXXX	KXXXXXX
	A Predicate Device	A Predicate Device	This Submission	This Submission	This Submission
Handheld	Yes	Yes	Yes	Yes	Yes
Wavelengths	605nm, 630nm, 660nm,855nm	610, 630 and 660, 850nm	610, 630 and 660, 850nm	610, 630 and 660, 850nm	610, 630 and 660, 850nm
Modes	On/Off	On/Off	On/Off	On/Off	On/Off
IR powersource	LEDs	LEDs	LEDs	LEDs	LEDs
Visible lightLEDs	Yes	Yes	Yes	Yes	Yes
Waveform	Constant	Constant	Constant	Constant	Constant
Energy Source	70 LEDs over 27 sq. cm.	40 LEDs. Over 20 sq. cm	40 LEDs. Over 20 sq. cm	24 LEDs. Over 8.7 sq. cm	24 LEDs. Over 15.2 sq. cm
Energy Level	65 mW total	65 mW total	65 mW total	65 mW total	65 mW total
Power Supply	115VAC Electric OutletPower Supply	115VAC Electric OutletPower Supply	115VAC Electric OutletPower Supply	115VAC Electric OutletPower Supply	115VAC Electric OutletPower Supply
TreatmentTime	3 minutes daily,minimum 5 days perweek	3 minutes daily,minimum 5 days perweek	3 minutes daily,minimum 5 days perweek	3 minutes daily,minimum 5 days perweek	3 minutes daily,minimum 5 days perweek
TargetPopulation	Individuals with faciallines and wrinkles.	Individuals withperiorbital lines and	Individuals with faciallines and wrinkles.	Individuals with faciallines and wrinkles.	Individuals with faciallines and wrinkles.

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Device					Location for Use
Light for Wrinkles	AAL OCT (K120775)LED IntellectualProperties LLC	A Predicate Device		wrinkles.	OTC
C100	Quasar Bio-Tech Inc	K112362	A Predicate Device		OTC
C100	Quasar Bio-Tech Inc	KXXXXXX	This Submission		OTC
Baby Quasar Plus	Quasar Bio-Tech Inc	KXXXXXX	This Submission		OTC
Quasar MD Plus	Quasar Bio-Tech Inc	KXXXXXX	This Submission		OTC

mmary of the technological characteristics of the device compared to predicate dev

are abovent grouped

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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 healthy 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.

A Human Factors Study for label comprehension and device use was conducted. The results of the HF Study found that the C100, Baby Quasar + and Quasar MD + have been found to be adequately safe and effective for the intended users, its intended uses, and use environments.

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, dose rates, performance, features, design materials, power output, technological properties, treatment areas, treatment regimes and methods of operation, the manufacturer believes that no significant differences exist between the device and the predicates listed in Section 5 Therefore substantial equivalency is requested.

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Image /page/6/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol on the right, consisting of three curved lines that resemble a person with outstretched arms. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all caps and is smaller than the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Silverbay LLC, d/b/a Quasar Biotech % AEGIS Regulatory, Inc. Ms. Susan Anthoney 2424 Dempster Drive Coralville, Iowa 52241

July 11, 2013

Re: K130225

Trade/Device Name: Quasar C100, Baby Quasar Plus, Quasar MD Plus; 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: June 11, 2013 Received: June 18, 2013

Dear Ms. Anthoney:

We have reviewed vour 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. Iisting 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

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Page 2 - Ms. Susan Anthoney

comply with all the Act's requirements, including, but not limited to: registration and listing (21 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 (OS) 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/CDRHOffices/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/Safetv/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson -S

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

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number: K130225

Device Name: Quasar C100, Baby Quasar Plus, Quasar MD Plus; 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 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.

(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__X (Optional Format 1-2-96)

زنرین Neil R Ogden 2013.07.11 09:24:16 -04'00'

(Division Sign-Off) for MXM

Division of Surgical Devices

510(k) Number _K130225

Silver Bay LLC

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.