The Clear Bi-Light is a hand-held, light emitting device for treating mild to moderate acne. The Clear Bi-Light is non-prescription and is intended for over-the-counter sale. Each Clear Bi-Light package includes the following:

One Clear Bi-Light rechargeable handpiece
Two Treatment Heads
- One blue light (405 - 420 nm)
- One red light (630 660 nm)
One Charger Stand
One AC adaptor power cord
One pair goggles
The Clear Bi-Light Instruction Manual

AI/ML Overview

I am sorry, but there is no information about acceptance criteria or a study proving device performance, sample sizes for test or training sets, data provenance, expert numbers and qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment within the provided text.

The document is a 510(k) premarket notification summary for a device called "Clear Bi-Light." It primarily focuses on demonstrating substantial equivalence to predicate devices based on technical specifications and non-clinical testing (biocompatibility, electrical safety, electromagnetic compatibility, photobiological safety, and software verification).

The document states:

Device Name: Clear Bi-Light
Indication for Use: Treatment of mild to moderate inflammatory acne.
Nonclinical Testing: Biocompatibility, Electrical Safety and Electromagnetic Compatibility, Photobiological Safety, and Software Verification and Validation. These tests confirm the device meets relevant safety standards and its software functions as designed.
Comparison to Predicate Devices: A detailed table compares the Clear Bi-Light's specifications (indication, energy source, wavelengths, controls, dose rate, temperature, dimensions, etc.) to three predicate devices (Tanda Mini, Silkn Blue, OmniLux Clear U) to argue for substantial equivalence.

However, it does not contain the following information typically found in clinical studies or performance evaluations:

Acceptance Criteria for Clinical Performance: No specific thresholds for efficacy (e.g., percentage reduction in lesions, success rates) are mentioned.
Reported Device Performance: There are no clinical outcomes (e.g., actual acne reduction percentages, user satisfaction rates) reported.
Sample Sizes: No mention of the number of subjects (patients) in any clinical study.
Data Provenance: No details on country of origin, retrospective/prospective nature of data.
Ground Truth Establishment: No information on how acne severity was measured or confirmed by experts.
Expert Qualifications/Adjudication: No details about experts, their number, or how their assessments were reconciled.
MRMC Study: No mention of human reader studies or improvements in human performance with AI assistance.
Standalone Performance: No algorithm-only performance metrics are provided, as this is a light-emitting device, not an AI diagnostic algorithm.
Training Set Details: Since this device is not an AI algorithm, there would be no "training set."

Therefore, I cannot provide the requested table and study details based on the provided text. The document focuses on demonstrating safety and technical equivalence to predicate devices rather than proving clinical efficacy with specific performance metrics from a user-facing study.

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, stacked on top of each other, with flowing lines connecting them.

Public Health Service

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

February 15, 2016

Michael Todd, LP % Sheila Hemeon-Heyer, JD, RAC Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, Massachusetts 01002

Re: K153081 Trade/Device Name: Clear Bi-light 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: January 20, 2016 Received: January 20, 2016

Dear Sheila Hemeon-Heyer:

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 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 of medical device

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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Jennifer R. Stevenson -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) K153081

Device Name Clear Bi-Light

Indications for Use (Describe)

The Clear Bi-Light is indicated for the treatment of mild to moderate inflammatory acne.

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

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

A.	Submitter:	Heyer Regulatory Solutions, LLCP.O. Box 2151Amherst, MA 01004-2151
	Contact:	Sheila Hemeon-HeyerSheila@heyer-regulatory.com

Device Manufacturer / 510(k) Applicant B.

	Michael Todd, LP
	648 Port St Lucie Blvd
	Port St Lucie, FL 34953
Contact:	Lilia Friend
	Senior Vice President
Tel:	(772) 343-0222
Email:	lil@michaeltoddusa.com

C. Date Prepared: October 23, 2015

Device Name and Classification Information: D.

Trade Name:	Clear Bi-Light
Common/usual Name:	Light Emitting Diode Therapy System
Classification Name:	Over-the-Counter Powered Light Based Laser forAcne
Product Code, CFR:	OLP, 21 CFR 878.4810
Review Panel:	General and Plastic Surgery Devices
Class:	II

E. Predicate Device: Tanda Mini Skincare System, K124042 Silkn Blue, K121435 OmniLux Clear U, K081307

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Device Description: ட்

One Clear Bi-Light rechargeable handpiece ●
Two Treatment Heads o
- O One blue light (405 - 420 nm)
- One red light (630 660 nm) o
One Charger Stand ●
One AC adaptor power cord ●
One pair goggles
The Clear Bi-Light Instruction Manual

Image /page/4/Figure/12 description: The image shows a Michael Todd Clear BIIGHT device with its charger stand. The device has a treatment head with LEDs covered by clear polycarbonate, which is referred to as the treatment head face. The device also has a power on/off button with an indicator light, a treatment head release lever, and a DC input for charging.

F. Indication for Use:

The Clear Bi-Light is indicated for the treatment of mild to moderate inflammatory acne.

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Section 8: 510(k) Summa

Technical Comparison with Predicate Devices க்

nformation for predicate devices was obtained from publicly available sources, including the 510(k) Summaries and device
nstruction manuals.

	Indication for Use	OTC or Rx?	Energy source	Treatment heads	Wavelength(s) (nm)	Comparison		Clear Bi-Light	Tanda Mini*K124042	Silkn BlueK121435	OmniLux Clear UK081307	Comparison
Clear Bi-Light	Indicated for the treatment of mild to moderate inflammatory acne.	OTC	LED	Separate Blue and Red, treatment heads	405-420630-660		Treatmentcontrol(s)	On/off button putsdevice in standbymodeContact sensor intreatment face,touching device toface activates LEDs	On/off button putsdevice in standbymodeContact sensor intreatment face,touching device toface activates LEDs	On/off button	Three positionswitch: Off - Blue- Red	All devices haveon/off button.Contact sensor inproposed device isthe same as in theTanda Mini.
Tanda Mini* K124042	Generally indicated to treat dermatological conditions. Specifically, Blue light modules are indicated to treat mild to moderate inflammatory acne.	OTC	LED	Blue only	$414 \pm 6$		Treatmentindicator(s)	Indicator light - Solidgreen whiletreatment is inprocess; blinkingindicates low battery.Audio signal: longbeep when power isturned on, short beepevery 30 secondsduring treatment;long beep at end of 3minute cycle	Indicator light -flashing green whentreatment is beingdeliveredAudio signal: onebeep every 30seconds duringtreatment; 2 beepsat end of treatmentor low battery; 3beeps signals hightemperature ontreatment head; 4beeps signalstreatment head isdisconnected.	Indicator light -Solid green whenready for treatmentor battery fullycharged; blinkinggreen for lowbattery; orange forbattery charging;	None	Indicator lightsubstantiallyequivalent to TandaMini and Silkn Blue.Audio signalsubstantiallyequivalent to TandaMini
Silkn Blue K121435	Indicated as an over the counter phototherapy device for the treatment of mild to moderate acne.	OTC	LED	Blue only	$415 \pm 15$	Same	Treatmenttimer	YesUp to 3 minutetreatment per areaafter which devicereturns to standbymode. Must presstreatment faceagainst skin toreactivate lights	YesUp to 3 minutetreatment per areaafter which deviceturns off. Mustpress power buttonto reactivate.	No	No	Substantiallyequivalent to TandaMini. Both deviceslimit each treatmentto 3 minutesegments.
OmniLux Clear U K081307	Indicated to treat mild to moderate acne on the face.	OTC	LED	Blue and Red in same head, chosen using selector switch	$415 \pm 5$$633 \pm 6$	Substantially equivalent. Minor wording differences do not change indication for use.
						Same as OmniLux (both offer separate blue and red light treatments). All devices offer blue light treatments. Substantially equivalent. Wavelengths are in the blue and red spectrum.

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Page 4 of 7

Section 8: 510(k) Summar

Michael Todd, LP
Clear Bi-Light 510(k)

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Treatmentregimen	Clear Bi-Light	Tanda Mini*K124042	Silkn BlueK121435	OmniLux Clear UK081307	Comparison
Dose rate(mW/cm²)	31.1 (blue)54.6 (red)	22.4	50	40 (blue)70 (red)	Substantially equivalent. Proposed treatment regimen is essentially the same as for Tanda Mini and Silkn Blue
Treatment facearea (cm²)	20	27	7	28.7	Substantially equivalent - within dose rate ranges of predicate devices
Max treatmenttemperature(°C)	38°C (blue)40°C (red)	39-43	41 ± 2	39-43	Substantially equivalent - within size ranges of predicate devices
Microprocessorcontrolled	Yes	Yes	Yes	Unknown	Substantially equivalent - within temperature ranges of predicate devices
Handheld	Yes	Yes	Yes	Yes	Same
Patientcontactingmaterials	Rigid ABSClear polycarbonatelens cover	Rigid ABS	Stainless steelRigid ABS	Rigid ABS	Substantially equivalent.Biocompatibility compliant with ISO 10993.
Treatmentregimen	Hold treatment facein contact with skin.Apply blue light forup to 3 minutes perskin area, followedby red light for up to3 minutes per skinarea. Can be useddaily.	Hold treatment facein contact with skinand apply blue lightfor up to 3 minutesper skin area. Canbe used daily	Hold treatment facein contact with skinfor 3 to 4 minutes,then move toanother area. Canbe used daily.	Alternatetreatments of blueand red light twicea week for 20minutes pertreatment	Same
	Clear Bi-Light	Tanda Mini*K124042	Silkn BlueK121435	OmniLux Clear UK081307	Comparison
Power supply	Lithium-ion rechargeable batteryAC charger: 100-240V at 50-60Hz, 500 mA	NiMH rechargeable battery or AC power supplyAC charger: 100-240V, 50-60 Hz, 400 mA	Lithium-ion rechargeable batteryAC charger: 100-240V, 50-60 Hz, 400 mA	"A separate, universal, power supply converts mains AC power to the DC power required"	Same as Silkn Blue
Dimensions	6.4 cm x 3.5 cm x 14.6 cm(2.5 in x 1.4 in x 5.7 in)	6.4 cm x 5.6 cm x 12.2 cm(2.5 in x 2.2 in x 4.8 in)	7.5 cm x 5 cm x 16.4 cm(3 in x 2 in x 6.5 in)	6 cm x 4 cm x 12 cm(2.4 in x 1.6 in x 4.7 in)	Substantially equivalent. All are small, hand-held devices.
Weight	107.1 g (6 oz)	340.2 g (12 oz)	231 g (8.1 oz)	Unknown	Substantially equivalent. All are light-weight, hand-held devices.

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ection 8: 510(k) Summa

There are e indication for use of the Clear Bi-Light device is the same as the technical specification
the Clear Bi-Light device are either the same or substantially equivaled the pred

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H. Nonclinical Testing

The following nonclinical testing was provided in this 510(k):

Biocompatibility Testing - The skin contacting material of the device (hydrogel) was subjected to biocompatibility testing per ISO 10993-1:2009, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing," for devices in contact with intact skin, including cytotoxicity, dermal sensitization, and dermal irritation. All tests passed.

Electrical Safety and Electromagnetic Compatibility Testing - The Clear Bi-Light has been tested and complies with the applicable requirements of the following standards for medical devices used in the home environment:

. IEC 60601-1:2005 Medical Electrical Equipment - Part 1: General Requirements for Safety, 3rd edition
IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, 300 edition

Photobiological Safety Testing - The Clear Bi-Light has been tested and complies with IEC 62471:2006-07, Photobiological safety of lamps and lamp systems, 186 edition. This IEC standard incorporates the principles of the following ANSI IESNA recommended practices:

o RP 27.1:2005 Recommended practice for photobiological safety for lamps and lamp systems - General requirements
RP 27.2:2000 Recommended practice for photobiological safety for lamps and lamp systems - Measurement techniques
RP-27.3:2007 Recommended practice for photobiological safety for lamps ● and lamp systems - Risk group classification and labeling

Software Verification and Validation - Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.

I. Conclusions

The information and testing presented in this 510(k) demonstrates that the Clear Bi-Light performs as designed and intended and is substantially equivalent for the treatment of mild to moderate inflammatory acne.

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.