The Poly Rejuv Model 633 is intended to emit energy in the red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

Device Description

The Poly Rejuv is a portable device that has a detachable treatment head, containing a total of 1,820 red 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 head) for the device. 12 pairs of protective eyewear are included with the device. The device is sold as Over the Counter (OTC) to commercial establishments only and not for home use. The Poly Rejuv is not intended to be used by laypersons. Poly Rejuv is intended to only be operated by a person who has been trained by the Sponsor according to their Customer Training Plan.

AI/ML Overview

The Poly Rejuv device (Model 633) is intended for dermatological use to treat periorbital wrinkles by emitting red region energy. The clearance is based on substantial equivalence to predicate devices, supported by non-clinical testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for the Poly Rejuv Model 633 does not explicitly state "acceptance criteria" in terms of clinical performance metrics (e.g., specific percentage reduction in wrinkles, or a statistical significance level for improvement). Instead, substantial equivalence is established through comparison of technological characteristics with a predicate device and extensive non-clinical (bench) testing. The "acceptance criteria" can be inferred as demonstrating that the device is as safe and effective as legally marketed predicate devices, with no new issues regarding safety and effectiveness.

The table below summarizes the key comparative characteristics presented in the 510(k) summary that serve as the basis for demonstrating this "acceptance."

Characteristic	Acceptance Criteria (based on predicate/reference devices)	Reported Poly Rejuv Model 633 Performance
Indications for Use	Treatment of periorbital wrinkles	Treatment of periorbital wrinkles
Wavelengths	630 +/- 3nm (Predicate)	633nm
Total Power Density (Red)	80 mW/cm² (Predicate K162098) / 65 mW/cm² (Reference K150098)	60 mW/cm²
Treatment Regimen	2 treatments per week for 6 weeks	2 treatments per week for 6 weeks
Treatment Time (per Tx)	3 minutes per target area (Predicate) / 3 minutes (Reference)	4 minutes
Standard Dose per treatment (Red)	14.4 J/cm² (Predicate)	14.4 J/cm²
Modes of Operation	ON/OFF	ON/OFF
Electrical Safety	Conformance to IEC60601-1	Conforms to IEC60601-1
EMC	Conformance to IEC 60601-1-2:2014	Conforms to IEC 60601-1-2:2014
Lamp Safety	Conformance to IEC 62471	Conforms to IEC 62471
Device Specific Safety	Conformance to IEC 60601-2-57:2011	Conforms to IEC 60601-2-57:2011
Usability	Conformance to IEC 62366-1 and IEC 60601-1-6	Conforms to IEC 62366-1 and IEC 60601-1-6
Software Validation	In accordance with FDA guidance	Software tested and validated
Performance Testing	Bench tests for Power Density, Timer, Functions, Use Life, Storage	Bench tests conducted

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

The submission does not describe a clinical study or a test set of data (e.g., patient data). The clearance is based on non-clinical (bench) testing and comparison of technical specifications to predicate devices. Therefore, there is no mention of sample size for a test set or data provenance from a human study.

The testing conducted was primarily hardware-related (electrical safety, EMC, lamp safety, device-specific safety, usability, and bench testing for power density, timer, functions, use life, and storage conditions) and software validation. These tests are conducted on the device itself, not on human subjects.

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, as no clinical test set or ground truth by medical experts was described for this 510(k) submission. The evaluation was based on engineering and performance standards conformance.

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

Not applicable, as no clinical test set requiring adjudication was described.

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. This device is an LED therapy system for wrinkle reduction, not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.

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

Not applicable. This is a physical medical device (LED therapy system), not an algorithm.

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

Not applicable, as no clinical ground truth from human studies was used for this 510(k) submission. The "ground truth" for the non-clinical testing was based on established engineering and safety standards (e.g., IEC standards) and the specified performance characteristics of the device and its predicates.

8. The sample size for the training set

Not applicable. As no artificial intelligence (AI) or machine learning (ML) algorithm is mentioned in the submission, there is no "training set" in that context. The device's software was subjected to validation testing, but this is distinct from training an AI model.

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

Not applicable, as no training set for an AI/ML algorithm was described.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

September 14, 2018

Medtek Skincare, LLC Susan Anthoney-Dewet FDA Consultant Aegis Regulatory, Inc. 2424 Dempster Drive Coralville, Iowa 52241

Re: K180875

Trade/Device Name: Poly Rejuv 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: March 16, 2018 Received: April 3, 2018

Dear Susan 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. 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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K180875

Device Name Poly Rejuv: Model 633

Indications for Use (Describe)

The Poly Rejuv Model 633 is intended to emit energy in the spectrum for use in dermatology for the treatment of periorbital wrinkles.

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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

K180875

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

Submission Date: March 27, 2018

1. Submitter Information:	AEGIS Regulatory, Inc. – Susan Anthoney-DeWe2424 Dempster DriveCoralville, IA 52241Tel.: 865-982-5552Email: sue@fdalistingconsultants.com
On behalf of Sponsor:	MedTek Skin Care, Inc.3 Depot St., Hudson Falls, NY 12839

2. General Information

2.1 Classification Name: Light Based Over-The-Counter Wrinkle Reduction Device
2.2 Common/Usual Name: Polychromatic LED Therapy System
2.3 Proprietary Names: Poly Rejuv, (POLY)Model 633
2.4 Classification: Class II
2.5 Classification Number: 878.4810
2.6 Product Code: OHS
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 Model 633:

K162098-LED Phototherapy Device (Li-Tek Electronic Technology Corporation)

3.2 Reference Devices :

1. K150098 LightStim Professional 2-Panel Light System (LED Intellectual)

{4}------------------------------------------------

1. K170187- Photodynamic Therapy Device (UV Biotek, LLC (now Medtek Skin Care))

4. Device Description:

The device is sold as Over the Counter (OTC) to commercial establishments only and not for home use.

The Poly Rejuv is not intended to be used by laypersons. Poly Rejuv 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 Rejuv Model 633 is intended to emit energy in the red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. (Product Code: OHS)

6. Comparison Of Technological Characteristics With The Predicate Device:

Table 1: Poly Rejuv Model 633 (Treatment head only contains red LEDs)

Please note that the proposed Poly Rejuv device below is identical in technology to reference device 2: Photodynamic Therapy Device, (K170187) (Red Treatment Head).

Device	ProposedPoly RejuvModel 633	PredicateLEDPhototherapyDevice(K162098)	ReferenceLightStimProfessional2-PanelLightSystem(K150098)	Remarks
IFU	The Poly RejuvModel 633 isintended to emitenergy in the redregion of thespectrum for usein dermatologyfor the treatmentof periorbitalwrinkles.	The red light isintended for thetreatment ofperiorbitalwrinkles.	System #1-emittingenergy in thevisible and IRspectrumsintended foruse in thetreatment offull-facewrinkles	SE

{5}------------------------------------------------

ProductCodes	OHS	OHS	OHS	SE
Wavelengths	633nm	630 +/- 3nm	Red andInfrared	SE
Total PowerDensity	Red: 60mW/cm2	Red: 80 mW/cm2	*65 mW/cm2	Similar toPredicate
TreatmentRegimen	2 treatments perweek for 6 weeks	2 treatments perweek for 6 weeks	Unknown* daily, 5 daysper week for 8weeksper their citedpredicatedevice.	SE
TreatmentTime (perTx)	4 minutes	3 minutes pertarget area	Unknown* 3 minutes,per their citedpredicatedevice.	Similar toPredicate
StandardDose pertreatment(mW/cm2*Tx timesec/1000)	Red: 14.4 J/cm2	Red: 14.4 J/cm2	Red andInfrared:15.6 J/cm2	SE
Modes	ON/OFF	ON/OFF	ON/OFF	SE
PowerSupply	100-240V,50/60Hz±2%,300VA	Lithium Battery	AC to DCpower supply	Similar toReferenceDevice
Number ofLEDs	1820 LEDs	Unknown	1130 LEDs	Similar toReferenceDevice
TreatmentArea	800cm2	30cm2±5%	Unknown-2 panelscontaining theLED array	Similar toReferenceDevice
Type anddistancefrom skin	Panels containingLED array- 6cmdistance from skin	Handheld deviceused 2-3 cmdistance fromskin	PanelscontainingLED array-unknowndistance fromskin	Similar toReferenceDevice
Rx or OTC	OTC-ProfessionalUse Only withCompany Training	OTC	OTC-CompanyTraining	Similar toReferenceDevice

{6}------------------------------------------------

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

The Poly Rejuv device Model 633 has the same indications for use, wavelengths, treatment regimen, standard dose per treatment, and modes of operation with similar power output as its cited predicate device.

The main technological differences between the Poly Rejuv device and the predicate device is 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. However, the Poly Rejuv device is similar to the reference device LightStim Professional 2-Panel Light System (K150098) 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 handhelddevices cleared under product code OHS with no clinical studies required. Performance Data i.e. bench testing and safety testing included in this submission shows that the Poly Rejuv device is at least as safe and effective as the predicate and reference devices.

7. Performance Data/Non-Clinical Testing:

The conclusions drawn from the nonclinical testing below demonstrate that the Poly Rejuv device is as safe, as effective, and performs as well as, or better than the legally marketed devices identified in section 3.

Safety Testing

The Poly Rejuv 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:

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:

{7}------------------------------------------------

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

USABILITY:

Recognition Number 5-114:

IEC 62366-1 Edition 1.0 2015-02. Medical Devices Part 1; Application Of . Usability Engineering To Medical Devices [Including Corrigendum 1 (2016)]. (General I (QS/RM))

Recognition Number 5-89:

IEC 60601-1-6 Edition 3.1 2013-10, Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability. (General I (QS/RM))
The Poly Rejuv device has been tested to ensure the device meets specifications:

BENCH TESTING:

Software Validation Testing The Poly Rejuvdevice'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 bench tests include tests for Power Density, Timer and Functions Test, Electrical Safety Test, Use Life Test, and Storage Condition Test.

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 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.