(164 days)
No
The summary describes a light therapy device with basic software for controlling treatment time and the treatment head. There is no mention of AI, ML, image processing, or any data-driven decision-making capabilities.
Yes
The device is described as "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," indicating that it has a therapeutic intent.
No
The device is described as emitting energy in the red region of the spectrum for the treatment of periorbital wrinkles, indicating a therapeutic rather than diagnostic function. It explicitly states "for use in dermatology for the treatment of periorbital wrinkles," not for diagnosing any condition.
No
The device description explicitly states it is a "portable device that has a detachable treatment head, containing a total of 1,820 red LEDs in the treatment head." It also mentions a "lifting stand," "main frame on a rolling stand," and a "display screen." These are all physical hardware components, indicating it is not a software-only device. While it does have software, it is integral to the operation of the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of periorbital wrinkles using red light energy. This is a therapeutic application, not a diagnostic one. IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a light-emitting device for direct application to the skin. There is no mention of collecting or analyzing biological samples.
- Lack of IVD-related information: The document does not contain any information typically associated with IVD devices, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection of specific analytes or biomarkers
- Diagnostic claims or interpretations based on test results
- Performance metrics like sensitivity, specificity, PPV, NPV, which are crucial for evaluating diagnostic accuracy.
The device is clearly intended for a therapeutic purpose (treating wrinkles) by applying light energy to the skin. This falls under the category of medical devices, but not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Poly Rejuv Model 633 is intended to emit energy in the spectrum for use in dermatology for the treatment of periorbital wrinkles.
Product codes (comma separated list FDA assigned to the subject device)
OHS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital
Indicated Patient Age Range
Not Found
Intended User / Care Setting
OTC-Professional Use Only with Company Training. Not intended to be used by laypersons. 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)
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:
- IEC60601-1 Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance
- 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
- IEC 62471 First Edition 2006-07, Photobiological Safety Of Lamps And Lamp . Systems. (Radiology)
- 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
- 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))
- 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))
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.
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.
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.
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
§ 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.
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)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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-DeWe
2424 Dempster Drive
Coralville, IA 52241
Tel.: 865-982-5552
Email: 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 :
-
- K150098 LightStim Professional 2-Panel Light System (LED Intellectual)
4
-
- K170187- Photodynamic Therapy Device (UV Biotek, LLC (now Medtek Skin Care))
4. 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.
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 | Proposed
Poly Rejuv
Model 633 | Predicate
LED
Phototherapy
Device
(K162098) | Reference
LightStim
Professional
2-Panel
Light
System
(K150098) | Remarks |
|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------|
| IFU | 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. | The red light is
intended for the
treatment of
periorbital
wrinkles. | System #1-
emitting
energy in the
visible and IR
spectrums
intended for
use in the
treatment of
full-face
wrinkles | SE |
5
| Product
| Codes | OHS | OHS | OHS | SE |
|---|---|---|---|---|
| Wavelengths | 633nm | 630 +/- 3nm | Red and | |
| Infrared | SE | |||
| Total Power | ||||
| Density | Red: 60mW/cm2 | Red: 80 mW/cm2 | *65 mW/cm2 | Similar to |
| Predicate | ||||
| Treatment | ||||
| Regimen | 2 treatments per | |||
| week for 6 weeks | 2 treatments per | |||
| week for 6 weeks | Unknown |
- daily, 5 days
per week for 8
weeks
per their cited
predicate
device. | SE |
| Treatment
Time (per
Tx) | 4 minutes | 3 minutes per
target area | Unknown - 3 minutes,
per their cited
predicate
device. | Similar to
Predicate |
| Standard
Dose per
treatment
(mW/cm2*
Tx time
sec/1000) | Red: 14.4 J/cm2 | Red: 14.4 J/cm2 | Red and
Infrared:
15.6 J/cm2 | SE |
| Modes | ON/OFF | ON/OFF | ON/OFF | SE |
| Power
Supply | 100-240V,
50/60Hz±2%,
300VA | Lithium Battery | AC to DC
power supply | Similar to
Reference
Device |
| Number of
LEDs | 1820 LEDs | Unknown | 1130 LEDs | Similar to
Reference
Device |
| Treatment
Area | 800cm2 | 30cm2±5% | Unknown-
2 panels
containing the
LED array | Similar to
Reference
Device |
| Type and
distance
from skin | Panels containing
LED array- 6cm
distance from skin | Handheld device
used 2-3 cm
distance from
skin | Panels
containing
LED array-
unknown
distance from
skin | Similar to
Reference
Device |
| Rx or OTC | OTC-Professional
Use Only with
Company Training | OTC | OTC-
Company
Training | Similar to
Reference
Device |
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.