(112 days)
Not Found
No
The device description focuses solely on the LED technology and its physical components. There is no mention of AI, ML, image processing, or any data processing that would suggest the use of such technologies. The operation is described as a simple timed treatment.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for treatment of wrinkles and mild to moderate inflammatory acne." The "Device Description" also refers to it as being "for the treatment of wrinkles and mild to moderate inflammatory acne."
No
Explanation: The device is described as an "Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne," and its description focuses on emitting light for treatment, not for diagnosing conditions.
No
The device description explicitly lists hardware components such as LEDs, a main device, head strap, eye rest, latch, user manual, storage bag, and USB power cord. It is a physical light-emitting device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Q-Rejuvalight Pro Facewear is a light-emitting device that applies energy directly to the skin for therapeutic purposes (treating wrinkles and acne). It does not analyze any biological samples.
- Intended Use: The intended use clearly states "treatment of wrinkles and mild to moderate inflammatory acne," which is a therapeutic application, not a diagnostic one.
The information provided describes a therapeutic device that uses light energy for dermatological conditions.
N/A
Intended Use / Indications for Use
The O-Rejuvalight Pro Facewear (Model: P19-0023) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.
Product codes
OHS, OLP
Device Description
The Q-Rejuvalight Pro Facewear is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles and mild to moderate inflammatory acne. The device uses four types of LEDs for Wrinkles: 605nm, 660nm, and 880nm and two types of LEDs for Acne: 415nm and 630nm. Each mode takes 3 minutes (±3s) for a course of treatment, and the mask will automatically turn off at the end of time.
The Q-Rejuvalight Pro Facewear components include the main device, head strap, eye rest, Latch, User Manual, Storage bag and USB power cord.
The Q-Rejuvalight Pro Facewear is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
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
Q-Rejuvalight Pro Facewear (Model: P19-0023) has been evaluated the safety and performance by lab bench testing as following:
| Standard No. | Standards Title | Version | Date |
|---|---|---|---|
| ANSI AAMI ES60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) | 2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] | 05/30/2022 |
| IEC 60601-1-11 | Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) | Edition 2.1 2020-07 CONSOLIDATED VERSION | 12/21/2020 |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | Edition 4.0 2014-02 | 09/17/2018 |
| IEC 60601-2-57 | 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 | Edition 1.0 2011-01 | 03/16/2012 |
| IEC 62133-2 | Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems | Edition 1.0 2017-02 | 12/23/2019 |
| IEC 62471 | Photobiological safety of lamps and lamp systems | First edition 2006-07 | 08/20/2012 |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Third edition 2009-06-01 | 12/23/2016 |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Fourth edition 2021-11 | 12/19/2022 |
| ISO 10993-23 | Biological evaluation of medical devices - Part 23: Tests for irritation | First edition 2021-01 | 06/07/2021 |
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject device Q-Rejuvalight Pro Facewear (Model: P19-0023) is as safe, as effective, and performs as well as or better than the legally marketed predicated devices K183247, K230124 and K171390.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 28, 2023
Light Tree Ventures Europe B.V. Alain Dijkstra Manager Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Hague, Netherlands
Re: K230042
Trade/Device Name: Q-Rejuvalight Pro Facewear (Model: P19-0023) 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. OLP Dated: February 27, 2023 Received: February 27, 2023
Dear Alain Dijkstra:
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
1
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 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 medical devices and radiation-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,
Jianting Wang -S
Jianting Wang Acting Assistant Director 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) K230042
Device Name
Q-Rejuvalight Pro Facewear (Model: P19-0023)
Indications for Use (Describe)
The O-Rejuvalight Pro Facewear (Model: P19-0023) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary of K230042
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Date of the summary prepared: April 3, 2023
2. Submitter's Information
Company Name: Light Tree Ventures Europe B.V. Address: Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Contact Person (including title): Alain Dijkstra (Manager) Tel: +86-135-10378748 Fax: +86-755-25024651 E-mail: regulation@kaiyanmedical.com
Manufacture
Company Name: Shenzhen Kaiyan Medical Equipment Co., Ltd Address: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China
Distributor
Company Name: Qure Skincare Pty Ltd Address: Level 1, 56 Clarence street NSW2000 Sydney Australia
Application Correspondent
Contact Person: Mr. Alain Dijkstra Company Name: Light Tree Ventures Europe B.V. Address: Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Tel: +86-135-10378748 Fax: +86-755-25024651 Email: regulation@kaiyanmedical.com
3. Subject Device Information
Type of 510(k): Traditional Classification Name: Light Based Over The Counter Wrinkle Reduction(OHS), Over-The-Counter Powered Light Based Laser For Acne(OLP) Trade Name: Q-Rejuvalight Pro Facewear
4
Model Name: P19-0023 Review Panel: General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 878.4810 Regulatory Class: II
4. Predicate Device Information
Predicate Device 1: Sponsor: LED Technologies, Inc. Trade Name: dpl® Faceware Classification Name: Light Based Over The Counter Wrinkle Reduction(OHS), Over-The-Counter Powered Light Based Laser For Acne(OLP) 510(k) Number: K183247 Review Panel: General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 21 CFR 878.4810 Regulation Class: II
Predicate Device 2:
Sponsor: Light Tree Ventures Europe B.V. Trade Name: LUSTRE ClearSkin Renew Pro Facewear Mask Classification Name: Light Based Over The Counter Wrinkle Reduction(OHS), Over-The-Counter Powered Light Based Laser For Acne(OLP) 510(k) Number: K230124 Review Panel: General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 21 CFR 878.4810 Regulation Class: II
Predicate Device 3:
Sponsor: LED Technologies, Inc. Trade Name: dpl® II Panel Classification Name: Light Based Over The Counter Wrinkle Reduction (OHS) 510(k) Number: K171390 Review Panel: General & Plastic Surgery Product Code: OHS Regulation Number: 21 CFR 878.4810
5
Regulation Class: II
5. Device Description
The Q-Rejuvalight Pro Facewear is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles and mild to moderate inflammatory acne. The device uses four types of LEDs for Wrinkles: 605nm, 660nm, and 880nm and two types of LEDs for Acne: 415nm and 630nm. Each mode takes 3 minutes (±3s) for a course of treatment, and the mask will automatically turn off at the end of time.
The Q-Rejuvalight Pro Facewear components include the main device, head strap, eye rest, Latch, User Manual, Storage bag and USB power cord.
The Q-Rejuvalight Pro Facewear is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components.
6. Intended Use / Indications for Use
The Q-Rejuvalight Pro Facewear (Model: P19-0023) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.
7. Test Summary
Q-Rejuvalight Pro Facewear (Model: P19-0023) has been evaluated the safety and performance by lab bench testing as following:
| Standard
| No. | Standards Title | Version | Date |
|---|---|---|---|
| ANSI AAMI | |||
| ES60601-1 | Medical electrical equipment - Part 1: General | ||
| requirements for basic safety and essential | |||
| performance (IEC 60601-1:2005, MOD) | 2005/(R)2012 & A1:2012, | ||
| C1:2009/(R)2012 & | |||
| A2:2010/(R)2012 (Cons. | |||
| Text) [Incl. AMD2:2021] | 05/30/2022 | ||
| IEC 60601- | |||
| 1-11 | Medical Electrical Equipment -- Part 1-11: | ||
| General requirements for basic safety and | |||
| essential performance -- Collateral Standard: | |||
| Requirements for medical electrical equipment | |||
| and medical electrical equipment and medical | |||
| electrical systems used in the home healthcare | |||
| environment (IEC 60601-1-11:2015 MOD) | Edition 2.1 2020-07 | ||
| CONSOLIDATED | |||
| VERSION | 12/21/2020 | ||
| IEC 60601- | |||
| 1-2 | Medical electrical equipment - Part 1-2: General | ||
| requirements for basic safety and essential | |||
| performance - Collateral Standard: | Edition 4.0 2014-02 | 09/17/2018 |
6
| Standard
| No. | Standards Title | Version | Date |
|---|---|---|---|
| Electromagnetic disturbances - Requirements | |||
| and tests | |||
| IEC 60601- | |||
| 2-57 | 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 | Edition 1.0 2011-01 | 03/16/2012 | |
| IEC 62133- | |||
| 2 | Secondary cells and batteries containing alkaline | ||
| or other non-acid electrolytes - Safety | |||
| requirements for portable sealed secondary cells, | |||
| and for batteries made from them, for use in | |||
| portable applications - Part 2: Lithium systems | Edition 1.0 2017-02 | 12/23/2019 | |
| IEC 62471 | Photobiological safety of lamps and lamp systems | First edition 2006-07 | 08/20/2012 |
| ISO | |||
| 10993-5 | Biological evaluation of medical devices - Part 5: | ||
| Tests for in vitro cytotoxicity | Third edition 2009-06-01 | 12/23/2016 | |
| ISO | |||
| 10993-10 | Biological evaluation of medical devices - Part 10: | ||
| Tests for irritation and skin sensitization | Fourth edition 2021-11 | 12/19/2022 | |
| ISO | |||
| 10993-23 | Biological evaluation of medical devices - Part 23: | ||
| Tests for irritation | First edition 2021-01 | 06/07/2021 |
8. Comparison to predicate device
| Elements of
Comparison | Subject
Device | Predicate
Device 1
(Primary) | Predicate
Device 2
(Reference) | Predicate
Device 3
(Reference) | Remark |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------|
| Company | Shenzhen
Kaiyan Medical
Equipment Co.,
Ltd | LED
Technologies,
Inc. | Light Tree
Ventures
Europe B.V. | LED
Technologies,
Inc. | -- |
| Trade Name | Q-Rejuvalight
Pro Facewear | dpl® Faceware | LUSTRE
ClearSkin
Renew Pro
Facewear
Mask | dpl® II Panel | -- |
| Classification
Name | Light Based
Over The
Counter
Wrinkle
Reduction(OH
S), Over-The-
Counter
Powered | Light Based
Over The
Counter
Wrinkle
Reduction(OH
S), Over-The-
Counter
Powered Light | Light Based
Over The
Counter
Wrinkle
Reduction(OH
S), Over-The-
Counter
Powered Light | Light Based
Over The
Counter
Wrinkle
Reduction
(OHS) | -- |
| Elements of
Comparison | Subject
Device | Predicate
Device 1
(Primary) | Predicate
Device 2
(Reference) | Predicate
Device 3
(Reference) | Remark |
| | Light Based
Laser For
Acne (OLP) | Based Laser
For Acne(OLP) | Based Laser
For Acne(OLP) | | |
| 510(k) Number | K230042 | K183247 | K230124 | K171390 | -- |
| Product Code | OHS, OLP | OHS, OLP | OHS, OLP | OLP | Same |
| Intended Use /
Indications for
Use | The Q-
Rejuvalight Pro
Facewear
(Model: P19-
0023) is an
Over-the-
Counter (OTC)
device
intended for
treatment of
wrinkles and
mild to
moderate
inflammatory
acne. | The dpl®
Faceware is an
Over-the-
Counter (OTC)
LED device
intended for
use in treating
wrinkles and
mild to
moderate
inflammatory
acne. | The LUSTRE
ClearSkin
Renew Pro
Facewear
Mask is an
over-the-
counter device
intended to
emit
energy in the
red and blue
region of the
light spectrum,
specifically
indicated to
treat mild to
moderate acne
vulgaris of the
face.
The LUSTRE
ClearSkin
Renew Pro
Facewear
Mask is an
over-the-
counter device
intended to
emit
energy in the
red and Near
Infra-red
spectrum and
is intended for
the use in the
treatment of
full-face
wrinkles. | The dpl® II
Panel is an
Over-the-
Counter (OTC)
device
intended for
use in treating
wrinkles. | Same |
| Power source | Input: 5V,
50/60Hz, 2A
Li-ion Polymer
Battery: 3.7V,
600mAh,
2.22Wh | Li-ion Battery
5V USB & 3.7
V Battery | Lithium battery:
3.7V, 1500mAh
5.55Wh
Adapter Input:
100-240Va.c.,
50/60Hz
Adapter
Output: 5Vd.c.,
1 A | 120-240V AC
Power Adapter | Similar
Note 1 |
| Elements of
Comparison | Subject
Device | Predicate
Device 1
(Primary) | Predicate
Device 2
(Reference) | Predicate
Device 3
(Reference) | Remark |
| Wavelengths | 605nm,
630nm,
660nm,
880nm,
415nm | 605nm,
630nm,
660nm,
880nm,
415nm | Red: 630±5nm
Blue: 415±5nm
NIF: 830±5nm | 605nm,
630nm,
660nm, 880nm | Same |
| Power Density | Single
wavelength:
605nm:
15±5mW/cm²
630nm:
20±5mW/cm²
660nm:
25±5mW/cm²
880nm:
10±5mW/cm²
415nm:
25±5mW/cm²
Total:
70mW/cm²(wri
nkle)
45mW/cm²(acn
e) | No publicly
available | Red: 18
mw/cm²
NIR: 12
mw/cm²
Total: 30
mw/cm²(wrinkl
e)
Blue: 26
mw/cm²
Red: 16
mw/cm²
Total: 42
mw/cm² (acne) | Total:
70.16mW/cm²(
wrinkle) | Similar
Note 2 |
| Irradiance
source | LEDs | LEDs | LEDs | LEDs | Same |
| Total Number
of LEDs | 80pcs | No publicly
available | 80pcs | No publicly
available | Same |
| LED
Distribution | 630nm+415nm
(Double wick):
30pcs
630nm+605nm
(Double wick):
25pcs
660nm+880nm
(Double wick):
25pcs | No publicly
available | 630nm+415nm
(Double wick):
30pcs
630nm+830nm
(Double wick):
50pcs | 630nm+830nm
(Double wick):
50pcs | Similar
Note 4 |
| Treatment area | 81(acne)
140(wrinkle) | 81(acne)
135.8(wrinkle) | No publicly
available | 415cm² | Same |
| Treatment time | 3 minutes per
treatment | 3 minutes per
treatment | 10 minutes | 3 minutes per
treatment | Same |
| Location for
Use | Face | Face | Face | Face | Same |
| Environment of
Use | OTC | OTC | OTC | OTC | Same |
| Safety and
EMC | IEC 60601-1
IEC 60601-1-
11
IEC 60601-1-2
IEC 60601-2-
57
IEC 62133-2 | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-
11
IEC 60601-1-2
IEC 60601-2-
57
IEC 62133-2 | IEC 60601-1
IEC 60601-1-2 | Similar
Note 3 |
| Elements of
Comparison | Subject
Device | Predicate
Device 1
(Primary) | Predicate
Device 2
(Reference) | Predicate
Device 3
(Reference) | Remark |
| | IEC 62471 | | IEC 62471 | | |
| Biocompatibility | ISO 10993-5
ISO 10993-10
ISO 10993-23 | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10
ISO 10993-23 | ISO 10993-10 | Same |
7
8
9
Comparison in details:
Note 1:
The description in "Power supply" of the subject device is slightly different from the predicate device, both of them use a Lithium-lon battery and are charged by the 5V USB. Besides, both the subject device and the predicate conducted the safety test according to the IEC 60601 series standards, and the test results are in compliance with safety standards' requirements. So, the difference between the subject device and the predicate device will not raise any safety or effectiveness issues.
Note 2:
Although there is no detailed information on the "Power Density" for each wavelength of predicate devices available, both the subject device and predicate device 3 have the same treatment wavelengths (605nm+630nm+660nm+880nm) and total power density designed in treating the wrinkles, both of the subject device and predicate device 2 have the same treatment wavelengths (630nm+415nm) and similar total power density designed in treating the acne. So, the slight difference between the subject device and the predicate devices will not raise any safety or effectiveness issues.
Note 3:
The description in "Safety and EMC" of the subject device is slightly different from the predicate device, both the subject device and the predicate conducted the electrical safety and electromagnetic compatibility tests according to the international series standards, and the test results are in compliance with standards' requirements. So, the difference between the subject device and the predicate device will not raise any safety or effectiveness issues.
Note 4:
Although the "LED Distribution" of the subject device is slightly different from the predicate devices, the subject device has the same/similar treatment parameters such as the treatment wavelengths and power density designed with the predicate devices. So, the difference between the subject device and the predicate device will not raise any safety or effectiveness issues.
10
9. Final Conclusion
The subject device Q-Rejuvalight Pro Facewear (Model: P19-0023) is as safe, as effective, and performs as well as or better than the legally marketed predicated devices K183247, K230124 and K171390.