The Poly Clear combination of Red (633nm=10mm) and Blue (417nm=10mm) is intended to emit energy in the red, blue regions of the light spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

Device Description

The Poly Clear is a portable device that has three separate detachable treatment heads, each containing a total of 1,820 LEDs in the treatment head. The treatment head is attached to a lifting stand that is attached to the main frame on a rolling stand. The user interface for applying treatment is a key lock to power ON/Off the device and a display screen attached to the main frame that runs the software (password protected-lockout code, runs treatment time/ treatment heads) for the device. 6 pairs of protective eyewear are included with the device.

AI/ML Overview

The provided text is a 510(k) summary for the Poly Clear device, which is a light therapy device for treating mild to moderate acne vulgaris. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical performance data.

Crucially, the document explicitly states that "no clinical studies required" (page 6). This means there are no acceptance criteria related to a clinical study demonstrating the device's efficacy in treating acne vulgaris, nor is there a study detailing device performance against such criteria.

The acceptance criteria provided in the document and the associated "study" (non-clinical testing) are focused on safety and technological equivalence.

Here's an analysis based on the information provided, highlighting the absence of clinical performance data:

1. A table of acceptance criteria and the reported device performance

The document does not present acceptance criteria for clinical performance (e.g., reduction in acne lesions) because it states no clinical studies were required. The "performance" discussed is primarily non-clinical.

Acceptance Criteria (Based on Non-Clinical Testing)	Reported Device Performance (Summary of Non-Clinical Testing)
Electrical Safety: Conformance to IEC60601-1	Tested and conforms to IEC60601-1.
EMC (Electromagnetic Compatibility): Conformance to IEC 60601-1-2:2014	Tested and conforms to IEC 60601-1-2:2014.
Lamp Safety (Photobiological Safety): Conformance to IEC 62471 First Edition 2006-07	Tested and conforms to IEC 62471 First Edition 2006-07.
Device Specific Safety (Non-Laser Light Source): Conformance to IEC 60601-2-57:2011	Tested and conforms to IEC 60601-2-57:2011.
Software Validation: Validated in accordance with FDA guidance for software in medical devices.	Software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices."
Performance Bench Tests: Spectral Transmittance of Eyewear, Power density, Timer and Functions Test, Electrical Safety Test, Use Life Test, and Storage Condition Test meet specifications.	The device has been tested to ensure it meets specifications for Spectral Transmittance of Eyewear, Power density, Timer and Functions Test, Electrical Safety Test, Use Life Test, and Storage Condition Test. (Specific results not detailed, but implied successful conformance).
Usability/Label Comprehension: Training is effective; intended users understand labeling and can apply information for primary operating functions.	Usability/Label Comprehension study results showed that training was effective and intended users were able to understand the labeling and apply this information to device use for the primary operating functions of the device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

For safety and bench testing: The document does not specify sample sizes (e.g., number of devices tested). These are typically laboratory tests on a representative number of units. The provenance is internal testing performed by the sponsor or contracted labs.
For usability testing: The document mentions "intended users" were involved in the Usability/Label Comprehension study, but does not state the sample size, country of origin, or whether it was prospective or retrospective. It's almost certainly prospective as it's a study conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. For non-clinical (engineering/safety) testing, "ground truth" is established by adherence to recognized international standards and specifications, rather than expert human assessment of medical images or conditions. For usability, the "ground truth" is the ability of intended users to successfully operate the device and understand instructions, as observed during the usability study, not by experts establishing clinical truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for interpreting diagnostic results or assessing patient outcomes, particularly when there is subjectivity. The provided non-clinical testing does not involve such methodologies.

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 Poly Clear device is a light therapy device, not an AI-powered diagnostic or assistive tool. No MRMC studies were conducted, as the device does not involve "human readers" or AI assistance in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The Poly Clear is a hardware device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is defined by:

International Consensus Standards: For electrical, EMC, and lamp safety, the ground truth is compliance with the specified IEC standards.
Device Specifications: For performance bench tests (e.g., power density, timer), the ground truth is meeting the manufacturer's defined specifications.
Observational Data/User Feedback: For usability testing, the ground truth is the successful demonstration of understanding and operation by the intended users during the study.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no training set, this question is not relevant.

In summary: The 510(k) submission for the Poly Clear device relies on demonstrating substantial equivalence through non-clinical testing (safety and performance bench tests) and comparative analysis of technological characteristics with predicate devices. No clinical studies were required, and therefore, no clinical performance acceptance criteria or corresponding clinical efficacy data are present in this document.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medtek Skincare, LLC % Susan Anthony-Dewet FDA Consultant FDA Regulatory Consultants, LLC 1604 NE 4th CT. Ft. Lauderdale, FL 33301

September 17, 2019

Re: K183708

Trade/Device Name: Poly Clear 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: August 26, 2019 Received: August 27, 2019

Dear Susan Anthony-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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Neil R.P. Ogden, MS Assistant Director, THT4A4 DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183708

Device Name Poly Clear

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

K183708

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

Submission Date: December 16, 2018

1. Submitter Information:	FDA Regulatory Consultants, LLC – Susan Anthoney-DeWet1604 NE 4th CTFort Lauderdale, FL 33301Tel.: 954-655-8846Email: sue@fdaregulatoryconsultant.com
On behalf of Sponsor:	MedTek Skin Care, Inc.3 Depot St., Hudson Falls, NY 12839Phone: 1-518-747-3310

2. General Information

2.1 Classification Name: Light Based Over-The-Counter Powered Light Based Laser For Acne

2.3 Proprietary Names: Poly Clear
2.4 Classification: Class II
2.5 Classification Number: 878.4810
2.6 Product Code: OLP
2.7 Regulation Medical Specialty: General & Plastic Surgery

2.8 Review Panel: Office of Device Evaluation (ODE) Division of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1)

3. Predicate Device(s):

3.1 Predicate Device for All Red, All Blue treatment heads:

K081307- Omnilux Clear-U (PhotoTherapuetics, Inc)

3.2 Predicate Device for Combo red/blue head:

K180900-LED Light Therapy Device, Model: KN-7000C (UV Biotek, LLC (now Medtek Skin Care))

3.3 Reference Devices :

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1. K151336 LightStim Professional 2-Panel Light System (LED Intellectual)
1. K170187- Photodynamic Therapy Device (UV Biotek, LLC (now Medtek Skin Care))

4. Device Description:

The Poly Clear is not intended to be used by laypersons. Poly Clear is intended to only be operated by a person who has been trained by the Sponsor according to their Customer Training Plan.

5. Indications / Intended Use:

The Poly Clear combination of Red (633nm±10nm) and Blue (417nm±10nm) is intended to emit energy in the red, blue regions of the light spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris. (Product Code: OLP)

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

Device	Proposed DevicePoly Clear(TBD)	PredicateDeviceOmnilux Clear-U(K081307)	ReferenceDevice #1LightStimProfessional 12-PanelLightSystem(K151336)	ReferenceDevice #2PhotodynamicTherapy DeviceModel:KN-7000A(K170187)	Remarks
Wavelengths	633±10nm417±10nm	633±6nm415±5nm	630nm, 415nm	633±10nm417±10nm	SE Note 1
Energy Level(mW/cm2)	All Red head:$60mW/cm^2±10mW/cm^2$All Blue head:$35mW/cm^2±10mW/cm^2$	Red: $70 mW/cm^2$Blue: $40 mW/cm^2$	Unknown	(1)Red head:$60mW/cm^2±10mW/cm^2$(2)Blue head:$35mW/cm^2±10mW/cm^2$	Similar toPredicate,identical toReferenceDevice# 2SE Note 2
Modes	ON/OFF	Three positionswitch: Off – ONBlue –ON Red	ON/OFF	ON/OFF	SE Note 1
Power Supply	100-240V,50/60Hz±2%, 300VA(Mains Connected)	AC to DC powersupply(Mains Connected)	AC to DCpower supply(Mains	100-240V,50/60Hz±2%,300VA	SE Note 1

Table 1: Predicate Chart -(All Red and All Blue Treatment Heads)

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			Connected)	(Mains Connected)
Number ofLEDs	Red Head: 1820Blue Head: 1820	180 LEDs	1130 LEDs perTreatmentHead	Red Head: 1820Blue Head: 1820	Similar toReferenceDevice#1,Identical toReferenceDevice #2SE Note 2
TreatmentArea	800cm2	28.7cm2 ±10%	Unknown-2 panelscontaining theLED array	800cm2	Similar toReferenceDevice #1,Identical toReferenceDevice #2SE Note 2
Type anddistance fromskin	Panels containing LEDarray- 6cm distance	Handheld, againstthe skin	PanelscontainingLED array-unknowndistance	Panels containingLED array- 6cmdistance	Identical toReferenceDevices 1& 2SE Note 2

Table 2: Poly Clear (Combo -Treatment head contains red and blue LEDs)

Device	Proposed DevicePoly Clear(TBD)	PredicateDeviceLED LightTherapyDeviceModel:KN-7000C(K180900)	ReferenceDevice #1LightStimProfessional2-Panel LightSystem(K151336)	ReferenceDevice#2PhotodynamicTherapy DeviceModel:KN-7000A(K170187)	Remarks
Wavelengths	633±10nm417±10nm	633±10nm417±10nm	630nm, 415nm	633±10nm417±10nm	SE Note 1
Energy Level(mW/cm2)	Combo Red/Blue head:Red:$30mW/cm^2±10$Blue:$20mW/cm^2±10$	Red:$45mW/cm^2±5$Blue:$25mW/cm^2±5$	Unknown	(3)Red/Blue head:•Red LEDs$30mW/cm^2±10mW/cm^2$•Blue LEDs$20mW/cm^2±10mW/cm^2$	SE-Similar toPredicate,IdenticaltoReferenceDevice #2SE Note 1
Modes	ON/OFF	ON/OFF	ON/OFF	ON/OFF	SE Note 1
PowerSupply	100-240V,50/60Hz±2%, 300VA(Mains Connected)	Rechargeable Li-Ion Batteries,with AC to DCpower supply	AC to DC powersupply(MainsConnected)	100-240V,50/60Hz±2%,300VA(Mains Connected)	Similar toReferenceDeviceSE Note 2
Number ofLEDs	Red:910Blue: 910	Red:48Blue:48	1130 LEDs perTreatment Head	Red:910Blue: 910	Similar toReference

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					DeviceSE Note 2
TreatmentArea	800cm2	$26cm2 \pm 10%$	Unknown-2 panelscontaining theLED array	800cm2	Similar toReferenceDeviceSE Note 2
Type anddistancefrom skin	Panels containing LEDarray- 6cm distance	Handheld,against the skin	Panels containingLED array-unknowndistance	Panels containingLED array- 6cmdistance	Similar toReferenceDeviceSE Note 2

SE Note 1: The Poly Clear device has the same indications for use, wavelengths, similar treatment regimen, and modes of operation with similar power output as their cited predicate device.

SE Note 2: The main technological differences between the Poly Clear device and the predicate devices are the number of LEDs, treatment area, type and distance used from skin (panel vs. handheld), power supply (battery vs mains), and intended operators of the device (OTC with Training provided by the sponsor). However, the Poly Clear device is similar to the reference device Photodynamic Therapy Device Model:KN-7000A (K170187) and similar to the reference device LightStim Professional 2-Panel Light System device (K151336) in these areas.

The sponsor is certain that the differences in the number of LEDs, treatment surface area, and distance used from skin (panel vs. handheld), does not affect the safety or efficacy of the device as there are a wide range of devices that have used predicate devices with different number of LEDs. different treatment areas, and panel vs handheld/mask devices cleared under device code OHS with no clinical studies required.

Performance Data i.e. bench testing and safety testing included in this submission shows that the Poly Clear device is substantially equivalent to the predicate and reference devices.

7. Performance Data/Non-Clinical Testing:

The conclusions drawn from the nonclinical testing below demonstrate that the Poly Clear device is substantially equivalent to the legally marketed devices identified in section 3.

Safety Testing

The Poly Clear device has been tested and conforms to international consensus standards:

ELECTRICAL SAFETY: Recognition Number 19-4:

IEC60601-1 Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance
EMC: Recognition Number 19-8:

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IEC 60601-1-2:2014 Medical Electrical Equipment-Part 1-2: General Requirements ● For Basic Safety And Essential Performance-Collateral Standard: Electromagnetic Compatibility - Requirements And Tests

LAMP SAFETY:

Recognition Number 12-249:

IEC 62471 First Edition 2006-07, Photobiological Safety Of Lamps And Lamp . Systems. (Radiology)

DEVICE SPECIFIC SAFETY:

Recognition Number 12-242:

. IEC 60601-2-57:2011 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
The Poly Clear device has been tested to ensure the device meets specifications:

BENCH TESTING:

. Software Validation Testing

The Poly Clear 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."

PERFORMANCE TESTING:

The performance bench tests include tests for Spectral Transmittance of Eyewear, Power density, Timer and Functions Test, Electrical Safety Test, Use Life Test, and Storage Condition Test.

USABILITY TESTING:

The sponsor conducted a Usability/Label Comprehension study to acquire data in order to evaluate and measure labeling comprehension, device usability, and training effectiveness by "intended users" of the Poly Clear device.

The results of this testing on the final version of the labeling and training plan showed that training was effective and intended users were able to understand the labeling and apply this information to device use for the primary operating functions of the device.

8. Substantial Equivalence Conclusion

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

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and the predicate and reference devices and no new issues arise for safety and effectiveness. Therefore substantial equivalency is hereby 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.