Who is the manufacturer of Poly Clear?

Medtek Skincare, LLC filed the 510(k) submission for Poly Clear (K183708).

What is the FDA product code for Poly Clear?

OLP. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Poly Clear?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Poly Clear?

Omnilux Clear-U (K081307); LED Light Therapy Device, Model: KN-7000C (K180900).

Who can help prepare an FDA 510(k) submission like Poly Clear?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Poly Clear

K183708 · Medtek Skincare, LLC · OLP · Sep 17, 2019 · General, Plastic Surgery

Device Facts

Record ID	K183708
Device Name	Poly Clear
Applicant	Medtek Skincare, LLC
Product Code	OLP · General, Plastic Surgery
Decision Date	Sep 17, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

Poly Clear is a portable, mains-powered LED light therapy device for clinical use; operated by personnel trained by the sponsor. Device features three detachable treatment heads, each containing 1,820 LEDs (or 910 red/910 blue in combo head), mounted on a rolling stand. User interface includes a key-lock power switch and a password-protected display screen for managing treatment time and head selection. Device emits red (633nm) and blue (417nm) light to treat mild to moderate acne vulgaris. Protective eyewear is provided. Healthcare providers use the device to deliver light energy to the skin at a 6cm distance. Clinical benefit is derived from phototherapeutic effects on acne-prone skin. Device is not for layperson/home use.

Clinical Evidence

Bench testing only. No clinical trials were conducted. Performance data included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), photobiological safety (IEC 62471), and device-specific safety (IEC 60601-2-57). Bench testing verified spectral transmittance, power density, timer accuracy, and device longevity. A usability/label comprehension study confirmed that trained users could effectively operate the device and understand labeling.

Technological Characteristics

Portable LED array system; 1,820 LEDs per head; 633nm (red) and 417nm (blue) wavelengths; 100-240V mains power; 6cm treatment distance. Complies with IEC 60601-1, IEC 60601-1-2, IEC 62471, and IEC 60601-2-57. Software-controlled via password-protected interface.

Indications for Use

Indicated for treatment of mild to moderate acne vulgaris in patients requiring dermatological light therapy.

Regulatory Classification

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.

Predicate Devices

Omnilux Clear-U (K081307)
LED Light Therapy Device, Model: KN-7000C (K180900)

Reference Devices

LightStim Professional 2-Panel Light System (K151336)
Photodynamic Therapy Device, Model: KN-7000A (K170187)

Related Devices

K043329 — OMNILUX REVIVE AND BLUE · Photo Therapeutics Limited · Mar 18, 2005
K081307 — OMNILUX CLEAR-U · Photo Therapeutics, Inc. · Jan 16, 2009
K160691 — Acne Light Therapy Wand · Zuko, Inc. · Jun 21, 2016
K170187 — Photodynamic Therapy Device · Uvbiotek, LLC · Jul 28, 2017
K070870 — SKIN CARE LIGHT · Transverse Industries Co. · Oct 10, 2007

Submission Summary (Full Text)

{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) - 2. 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) | (Mains 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.