The Sonilase Blue-UV Clean is a hand held OTC device intended to emit energy in the light spectrum for use in the treatment of mild to moderate acne vulgaris.

The Sonilase Blue-UV Clean Plus is a hand held OTC device intended to emit energy in the blue region of the light spectrum for use in the treatment of mild to moderate acne vulgaris.

Device Description

The Sonilase Blue, Sonilase Blue-Clean, and Sonilase Blue-UV Clean Plus are modular system devices that offer blue light therapy for the treatment of mild to moderate acne vulgaris.

The Sonilase Blue device components include the handheld unit containing the LED module with 3 (415nm) LEDs . attachable clear plastic lens cover. an adjunct attachable cleansing brush head, recharging stand, 7.4 v LI-ION BATTERY, 9V UL approved power supply and goggles.

The Sonilase Blue-Clean device components include the handheld unit containing the LED module with 3 blue LEDs (415nm) attachable opaque lens cover, an adjunct attachable cleansing brush head. recharging stand. 7.4 v LI-ION BATTERY. 9V UL approved power supply and goggles.

The Sonilase Blue-UV Clean Plus device components include the handheld unit containing the LED module with 3 blue LEDs (415nm) and 3 UV sanitizing LEDs , attachable opaque lens cover, a detachable cleansing brush head, recharging stand, 7.4 v LI-ION BATTERY, 9V UL approved power supply and goggles.

The Sonilase Blue, Sonilase Blue-UV Clean, and Sonilase Blue-UV Clean Plus devices operate by a cordless system drawing upon their 7.4V rechargeable LI-ION battery to deliver the treatment.

The Sonilase Blue. Sonilase Blue-Clean, and Sonilase Blue-UV Clean Plus utilize blue light at 415 nm +/- 5nm.

The Sonilase Blue is applied directly to the skin to ensure consistent administration of light during each treatment.

The Sonilase Blue-Clean and Sonilase Blue-UV Clean Plus are applied to the skin with the cleansing brush still attached, but the amount of treatment energy (Dose) delivered to the skin is the same.

The Sonilase Blue, Sonilase Blue-Clean, and Sonilase Blue-UV Clean Plus have a skin sensor that will not allow the device to illuminate unless it is in contact with the skin as a safety feature.

The Sonilase Blue, Sonilase Blue- Clean, and Sonilase Blue-UV Clean Plus devices do not contain any user serviceable components. The devices are sold as Over the Counter (OTC).

AI/ML Overview

The provided document is a 510(k) premarket notification for three medical devices: Sonilase Blue, Sonilase Blue-Clean, and Sonilase UV-Clean Plus. These devices are intended for the treatment of mild to moderate acne vulgaris. The document demonstrates substantial equivalence to predicate devices, primarily K121435 - Silk'n Blue and K124042 - Tanda Mini Skincare System.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Sonilase Blue series of devices are implicitly defined by their substantial equivalence to the predicate devices and their compliance with relevant international consensus standards. The performance reported focuses on meeting these technical specifications and demonstrating user safety and comprehension.

Acceptance Criterion (Implicitly from Predicate Comparison & Standards)	Reported Device Performance (Sonilase Blue Series)
Intended Use (Treatment of mild to moderate acne vulgaris)	Same intended use as predicate devices.
Output Energy Level (50 mW/cm²)	The device emits at least 50 mW/cm².
Wavelength (415 nm)	The device utilizes 415 nm +/- 5nm blue light.
Standard Dose (12 J/cm²)	Utilizes the same standard dose (12 J/cm²) as the predicate device.
Handheld Design	Yes, the device is handheld.
Power Source (LEDs)	Utilizes LEDs (3 blue LEDs).
Method of Delivery (Blue light administered through treatment head)	Blue light treatment administered through treatment head (or lens/brush).
Treatment Time (e.g., 3-4 minutes daily, for 3-7 weeks for predicate)	4 minutes per area, daily.
Target Population (Individuals with mild to moderate acne)	Individuals with mild to moderate acne.
Location for Use (OTC)	OTC.
Electrical Safety (Conforms to IEC/EN 60601-1:2005)	Conforms to IEC/EN 60601-1:2005 Edition 3/(R)2012 And A1:2012.
Performance Standard (Conforms to IEC 60601-2-57:2011-01)	Conforms to IEC 60601-2-57 Edition 1.0 2011-01.
EMC Standard (Conforms to IEC 60601-1-2 Ed. 3:2007-03)	Conforms to IEC 60601-1-2 Edition 3: 2007-03.
Software Validation (According to FDA Guidance)	Software was tested and validated in accordance with FDA guidance.
User Label Comprehension	100% of participants were able to comprehend the labeling.
Successful Device Usage	97% of participants were able to use the device successfully.

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

Sample Size for Usability/Label Comprehension Study: 39 participants.
Data Provenance: The document does not specify the country of origin or whether the study was retrospective or prospective for the usability study. It is implied to be a prospective usability study since participants "were able to comprehend the labeling" and "use the device successfully."

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

The document does not mention the use of experts to establish 'ground truth' in the context of acne treatment efficacy. The studies described are centered around engineering performance, electrical safety, EMC, and user comprehension/usability for an OTC device. For the usability/label comprehension study, there were no "experts" establishing ground truth in the clinical sense; rather, the participants themselves provided the data on comprehension and usage success.

4. Adjudication Method for the Test Set

Not applicable in the context of the reported studies. The usability/label comprehension study involved direct observation and assessment of participant interaction, not a multi-reader review process.

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. The device is a blue light therapy device for acne, not an AI-powered diagnostic or interpretive tool that would involve human "readers" or AI assistance.

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

Not applicable. The device is a physical light therapy device, not an algorithm. Its performance is inherent in its physical and electrical characteristics and ability to deliver blue light.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the engineering and safety tests, the "ground truth" is defined by the objective standards themselves (e.g., IEC standards). For the usability/label comprehension study, the "ground truth" was established by the participants' direct experience and performance (comprehension and successful usage). There is no mention of clinical efficacy studies or ground truth related to clinical outcomes like pathology or expert consensus on acne improvement in this 510(k) summary, as it relies on substantial equivalence to existing devices for clinical claims.

8. The Sample Size for the Training Set

Not applicable. The reported studies (electrical safety, performance, EMC, software validation, usability) do not involve machine learning algorithms requiring training sets.

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

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center of the logo is an abstract symbol of a human figure, represented by three overlapping profiles.

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

December 30, 2015

Biorenew Labs, LLC c/o Susan Anthoney-Dewet Aegis Regulatory, Inc. 2424 Dempster Drive Coralville, IA 52241

Re: K152889

Trade/Device Name: Sonilase Blue Blue, Sonilase Blue-Clean, Sonilase UV-Clean Plus 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: OLP Dated: September 29, 2015 Received: September 30, 2015

Dear Ms. Anthoney-Dewet:

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, listing 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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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 (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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

David Krause -S

for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152889

Device Name

Sonilase Blue, Sonilase Blue-UV Clean, and Sonilase Blue-UV Clean Plus

Indications for Use (Describe)

The Sonilase Blue is a hand held OTC device intended to emit energy in the light spectrum for use in the treatment of mild to moderate acne vulgaris.

The Sonilase Blue-UV Clean is a hand held OTC device intended to emit energy in the light spectrum for use in the treatment of mild to moderate acne vulgaris.

The Sonilase Blue-UV Clean Plus is a hand held OTC device intended to emit energy in the blue region of the light spectrum for use in the treatment of mild to moderate acne vulgaris.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CER 801 Subpart D)
Over-The-Counter Use (21 CER 801 Subpart C)	X

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510(k) Summary

K152889

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

Submission Date: September 16, 2015

1. Submitter Information: AEGIS Regulatory, Inc. - Susan Anthoney-DeWet 2424 Dempster Drive Coralville, IA 52241 Tel.: 865-982-5552

Email: sue@fdalistingconsultants.com

For Specifications Developer: Biorenew Labs, LLC

Attn: Jon David 415 Pier Avenue Hermosa Beach, CA 90254 Tel.: 310-400-0631 Email: jon@biorenewlabs.com

2. General Information

2.1 Classification Name: Light Based Over-The-Counter Powered Light Based Laser For Acne
2.2 Common/Usual Name: Sonilase Blue, Sonilase Blue-Clean, and Sonilase UV-Clean Plus

Light Devices

2.3 Proprietary Names: Sonilase Blue, Sonilase Blue- Clean, and Sonilase UV-Clean Plus Light
Devices
2.4 Classification: Class II
2.5 Classification Number: 878.4810
2.6 Product Code: OLP
1. Device Description:

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The Sonilase Blue, Sonilase Blue-Clean, and Sonilase Blue-UV Clean Plus are modular system devices that offer blue light therapy for the treatment of mild to moderate acne vulgaris.

The Sonilase Blue, Sonilase Blue-UV Clean, and Sonilase Blue-UV Clean Plus devices operate by a cordless system drawing upon their 7.4V rechargeable LI-ION battery to deliver the treatment.

The Sonilase Blue. Sonilase Blue-Clean, and Sonilase Blue-UV Clean Plus utilize blue light at 415 nm +/- 5nm.

The Sonilase Blue is applied directly to the skin to ensure consistent administration of light during each treatment.

The Sonilase Blue-Clean and Sonilase Blue-UV Clean Plus are applied to the skin with the cleansing brush still attached, but the amount of treatment energy (Dose) delivered to the skin is the same.

The Sonilase Blue, Sonilase Blue-Clean, and Sonilase Blue-UV Clean Plus have a skin sensor that will not allow the device to illuminate unless it is in contact with the skin as a safety feature.

The Sonilase Blue, Sonilase Blue- Clean, and Sonilase Blue-UV Clean Plus devices do not contain any user serviceable components. The devices are sold as Over the Counter (OTC).

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4. Indications / Intended Use:

The Sonilase Blue is a hand held OTC device intended to emit energy in the light spectrum for use in the treatment of mild to moderate acne vulgaris.

The Sonilase Blue- Clean is a hand held OTC device intended to emit energy in the light spectrum for use in the treatment of mild to moderate acne vulgaris.

The Sonilase Blue-UV Clean Plus is a hand held OTC device intended to emit energy in the light spectrum for use in the treatment of mild to moderate acne vulgaris.

Rx or OTC:

The Sonilase Blue series of light device are Over the Counter (OTC) devices. 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:

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

Primary Predicate Device: K121435 - Silk'n Blue (Home Skinovations LTD)

Secondary Predicate Device: K124042 – Tanda Mini Skincare System (Syneron Beauty Inc.)

Predicate Chart

Silk 'N Blue	Tanda Mini SkincareSystem	Sonilase Blue-Acne	Sonilase Blue-Clean	Sonilase Blue-UV CleanPlus
Home SkinovationsLTD.	Syneron Beauty Inc.	Model-SL113B	Model-SL113BC	Model-SL113BUV+
K121435	K124042	Biorenew Labs, LLC	Biorenew Labs, LLC	Biorenew Labs, LLC
A Predicate Device	A Predicate Device	K152889This Submission	K152889This Submission	K152889This Submission

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Device	Silk 'N Blue	Tanda Mini SkincareSystem	Sonilase Blue-Acne	Sonilase Blue-Clean	Sonilase Blue-UV CleanPlus
	Home SkinovationsLTD.	Syneron Beauty Inc.	Model-SL113B	Model-SL113BC	Model-SL113BUV+
	K121435	K124042	Biorenew Labs, LLC	Biorenew Labs, LLC	Biorenew Labs, LLC
	A Predicate Device	A Predicate Device	K152889	K152889	K152889
			This Submission	This Submission	This Submission
Indications		The Tanda Mini SkincareSystem is generallyindicated to treatdermatologicalconditions. Specifically,blue light modules areindicated to treat mild tomoderate inflammatoryacne.	The Sonilase Blue is ahand held OTC deviceintended to emit energyin the blue region of thelight spectrum for use inthe treatment of mild tomoderate acne vulgaris..	The Sonilase Blue-Cleanis a hand held OTC deviceintended to emit energyin the blue region of thelight spectrum for use inthe treatment of mild tomoderate acne vulgaris	The Sonilase Blue-UVClean Plus is a hand heldOTC device intended toemit energy in the blueregion of the lightspectrum for use in thetreatment of mild tomoderate acne vulgaris
Handheld	Yes	Yes	Yes	Yes	Yes
Wavelength	415 nm +/- 15nm	414 nm +/- 6nm	415 nm +/- 5nm	415 nm +/5nm	415 nm +/5nm
Modes	On/Off	On/Off	On/Off	On/Off	On/Off
Blue powersource	LEDs	LEDs	LEDs	LEDs	LEDs
Energy Source	24 LEDs . Over 7 cm2	7 LEDs. Unknown area.	3 LEDs. Over 9.6 cm2	3 LEDs. Over 9.6 cm2	3 LEDs. Over 9.6 cm2
Energy Level	50 mW/cm2	22.4 mW/cm2	50 mW/cm2	50 mW/cm2	50 mW/cm2
Method ofDelivery	Blue light treatmentadministered throughstainless steel treatmenthead containing LED	Blue light treatmentadministered throughtreatment head.	Blue light treatmentadministered throughtreatment head.	Blue light treatmentadministered throughlens or brush.	Blue light treatmentadministered throughlens or brush.
Device	Silk 'N BlueHome Skinovations LTD.K121435A Predicate Device	Tanda Mini Skincare SystemSyneron Beauty Inc.K124042A Predicate Device	Sonilase Blue-AcneModel-SL113BBiorenew Labs, LLCK152889This Submission	Sonilase Blue-CleanModel-SL113BCBiorenew Labs, LLCK152889This Submission	Sonilase Blue-UV Clean PlusModel-SL113BUV+Biorenew Labs, LLCK152889This Submission
	array.
Power Supply	Unknown	One 9v rechargeable alkaline battery	One 7.4v rechargeable LI-ION BATTERY	One 7.4v rechargeable LI-ION BATTERY	One 7.4v rechargeable LI-ION BATTERY
TreatmentTime	* 3-4 minutes daily, for 3-7 weeks	*2 minutes, 3 times per day.	4 minutes per area, daily.	4 minutes per area, daily.	4 minutes per area, daily.
TargetPopulation	Individuals with mild to moderate acne	Individuals with mild to moderate acne	Individuals with mild to moderate acne	Individuals with mild to moderate acne	Individuals with mild to moderate acne
Location forUse	OTC	OTC	OTC	OTC	OTC

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

Has the same intended use as the predicate (i.e., Treatment of mild to moderate acne vulgaris;
Has the same output (i.e., 50 mW/cm2 ) as the predicate;
Utilizes the same wavelength (i.e., 415 nm) as the predicate device;
Utilizes the same standard dose (i.e., 12J/cm2) as the predicate device;

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The Sonilase Blue Light Devices and the above referenced predicate devices are Over the Counter Devices used to treat mild to moderate acne vulgaris as defined in 21 CFR § 878.4810. These devices at 415nm to provide narrow bands of light energy to treat acne vulgaris. 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. They are manufactured out of similar materials. Based upon comparison to the predicate device, the Sonilase Blue 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. Technological Characteristics

The Sonilase Blue light delivery system used for applying therapy for the treatment of acne vulgaris, by emitting at least 50 mW/cm² of blue (415 nm +/- 5nm) light via an electic light emitting diodes [LEDs] energy source. There are 3 blue LEDs in the head. The LED head size is 9.6cm².

The Sonilase Blue- Clean light delivery system used for applying the treatment of acne vulgaris, by emitting at least 50 mW/cm² of blue (415 nm +/- 5nm) light via an electric light emitting diodes [LEDs] energy source, transmitted through the cleansing brush head. There are 3 blue LEDs in the head. The LED head size is 9.6cm².

The Sonilase Blue-UV Clean Plus light delivery system used for the treatment of acne vulgaris, by emitting at least 50 mW/cm² of blue (415 nm +/- 5nm) light via an electric light emitting diodes [LEDs] energy source, transmitted through the cleansing brush head. There are 3 blue LEDs in the head. The LED head size is 9.6cm².

The Sonilase Blue, Sonilase Blue-UV Clean Plus devices are not intended for ocular applications or direct eve exposure.

7. Performance Testing and Standards:

Testing of the Sonilase Blue series of devices included functional performance testing, software validation testing and user safety testing.

The results of this testing are as follows:

Conforms to international consensus standards:

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ELECTRICAL SAFETY:

Recognition Number 19-4:

IEC/EN 60601-1:2005 Edition 3/(R)2012 And A1:2012 Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance (lec 60601-1:2005, Mod). (General II (ES/EMC))

PERFORMANCE:

Recognition Number 12-242:

· IEC 60601-2-57 Edition 1.0 2011-01, Medical Electrical Equipment -- Part 2-57: Particular Requirements For The Basic Safety And Essential Performance Of Non-Laser Light Source Equipment Intended for Therapeutic Diagnostic Monitoring and Cosmetic/Aesthetic Use (Radiology)

EMC:

Recognition Number 19-1:

IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment Part 1-2: General Requirements For Basic Safety And . Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests. (General II (ES/EMC))
The Sonilase Blue series of device's software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices,"

A Usability/Label Comprehension Study was conducted with 39 participants.

The results of the study found that:

100% of the participants were able to comprehend the labeling.

97% of the participants were able to use the device successfully.

User Safety testing reflects device can be used in a safe and effective manner.

9. Substantial Equivalence Conclusion

After an analysis of the safety, intended uses, performance, design materials, power output, technological

properties, treatment areas, and treatment regimes the manufacturer believes that no significant differences exist between the

device and the predicate device. Therefore substantial equivalency is requested.

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.