Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a light therapy device with basic software for controlling treatment time and heads. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies. The software testing is described as conforming to standard software guidance, not AI/ML specific guidance.

Therapeutic

Yes.
The device's intended use is to "treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris," which is a therapeutic purpose.

Diagnostic

No

The device is intended to treat dermatological conditions using light energy, which is a therapeutic function, not a diagnostic one. There is no mention of it analyzing patient data or providing diagnostic information.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical hardware components including LED treatment heads, a lifting stand, a main frame on a rolling stand, a key lock, and a display screen. While it mentions software running on the display screen, it is integral to the operation of the physical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris." This is a therapeutic treatment applied directly to the patient's skin.
Device Description: The device is a light therapy device that emits light onto the skin.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are used to diagnose diseases or conditions in vitro (outside the body).

This device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

OLP

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

"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."

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Type: Non-clinical testing: Safety Testing, Bench Testing (Software Validation, Performance Testing), Usability Testing.

Key Results:

Safety Testing: The Poly Clear device has been tested and conforms to international consensus standards: IEC60601-1 (Electrical Safety), IEC 60601-1-2:2014 (EMC), IEC 62471 First Edition 2006-07 (Lamp Safety), and IEC 60601-2-57:2011 (Device Specific Safety).
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: Included 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. The 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.

Overall Conclusion: The conclusions drawn from the nonclinical testing demonstrate that the Poly Clear device is substantially equivalent to the legally marketed devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K081307, K180900

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K151336, K170187

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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

1

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

2

Indications for Use

510(k) Number (if known) K183708

Device Name Poly Clear

Indications for Use (Describe)

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.

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

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-DeWet
1604 NE 4th CT
Fort Lauderdale, FL 33301Tel.: 954-655-8846
Email: sue@fdaregulatoryconsultant.com |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| On behalf of Sponsor: | MedTek Skin Care, Inc.
3 Depot St., Hudson Falls, NY 12839
Phone: 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 :

4

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 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.

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 Device
Poly Clear
(TBD) | Predicate
Device
Omnilux Clear-U
(K081307) | Reference
Device #1
LightStim
Professiona
l 12-Panel
Light
System
(K151336) | Reference
Device #2
Photodynamic
Therapy Device
Model:KN-
7000A
(K170187) | Remarks |
|--------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Wavelengths | 633±10nm
417±10nm | 633±6nm
415±5nm | 630nm, 415nm | 633±10nm
417±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 to
Predicate,
identical to
Reference
Device# 2
SE Note 2 |
| Modes | ON/OFF | Three position
switch: Off – ON
Blue –ON Red | ON/OFF | ON/OFF | SE Note 1 |
| Power Supply | 100-240V,
50/60Hz±2%, 300VA
(Mains Connected) | AC to DC power
supply
(Mains Connected) | AC to DC
power supply
(Mains | 100-240V,
50/60Hz±2%,
300VA | SE Note 1 |

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

5

			Connected)
Number of
LEDs	Red Head: 1820
Blue Head: 1820	180 LEDs	1130 LEDs per
Treatment
Head	Red Head: 1820
Blue Head: 1820	Similar to
Reference
Device#1,
Identical to
Reference
Device #2
SE Note 2
Treatment
Area	800cm2	28.7cm2 ±10%	Unknown-
2 panels
containing the
LED array	800cm2	Similar to
Reference
Device #1,
Identical to
Reference
Device #2
SE Note 2
Type and
distance from
skin	Panels containing LED
array- 6cm distance	Handheld, against
the skin	Panels
containing
LED array-
unknown
distance	Panels containing
LED array- 6cm
distance	Identical to
Reference
Devices 1
& 2
SE Note 2

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

| Device | Proposed Device
Poly Clear
(TBD) | Predicate
Device
LED Light
Therapy
Device
Model:KN-
7000C
(K180900) | Reference
Device #1
LightStim
Professional
2-Panel Light
System
(K151336) | Reference
Device#2
Photodynamic
Therapy Device
Model:KN-7000A
(K170187) | Remarks |
|--------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Wavelengths | 633±10nm
417±10nm | 633±10nm
417±10nm | 630nm, 415nm | 633±10nm
417±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 to
Predicate,
Identical
to
Reference
Device #2
SE Note 1 |
| Modes | ON/OFF | ON/OFF | ON/OFF | ON/OFF | SE Note 1 |
| Power
Supply | 100-240V,
50/60Hz±2%, 300VA
(Mains Connected) | Rechargeable Li-
Ion Batteries,
with AC to DC
power supply | AC to DC power
supply
(Mains
Connected) | 100-240V,
50/60Hz±2%,
300VA
(Mains Connected) | Similar to
Reference
Device
SE Note 2 |
| Number of
LEDs | Red:910
Blue: 910 | Red:48
Blue:48 | 1130 LEDs per
Treatment Head | Red:910
Blue: 910 | Similar to
Reference |

6

| | | | | | Device
SE Note 2 |
|-----------------------------------|----------------------------------------------|-------------------------------|--------------------------------------------------------|-------------------------------------------------|------------------------------------------------|
| Treatment
Area | 800cm2 | $26cm2 \pm 10%$ | Unknown-
2 panels
containing the
LED array | 800cm2 | Similar to
Reference
Device
SE Note 2 |
| Type and
distance
from skin | Panels containing LED
array- 6cm distance | Handheld,
against the skin | Panels containing
LED array-
unknown
distance | Panels containing
LED array- 6cm
distance | Similar to
Reference
Device
SE 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:

7

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

8

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