(127 days)
No
The description focuses on LED light wavelengths and vibration modes, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes.
The device is intended to treat full face wrinkles and mild to moderate inflammatory acne, which are therapeutic indications.
No
The device description indicates that the TheraFace Mask uses LED light for treatment purposes (treating wrinkles and acne) and vibration for relaxation, but it does not mention any function for diagnosing conditions.
No
The device description clearly outlines a physical mask with LEDs, vibration motors, batteries, and buttons. It is a hardware device that utilizes light and vibration for therapeutic purposes.
Based on the provided information, the TheraFace Mask device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- TheraFace Mask Function: The TheraFace Mask uses LED light and vibration applied directly to the skin of the face. It does not analyze any biological specimens.
- Intended Use: The intended uses are for treating wrinkles and acne, and for general relaxation. These are therapeutic and cosmetic applications, not diagnostic ones based on analyzing biological samples.
Therefore, the TheraFace Mask falls under the category of a therapeutic or cosmetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
- Red Light is intended to treat full face wrinkles
- Blue Light is intended to treat mild to moderate inflammatory acne
- Red + Infrared Light is intended to treat full face wrinkles
Product codes (comma separated list FDA assigned to the subject device)
OHS, OLP
Device Description
The TheraFace Mask device is a lightweight device which uses specified wavelengths of LED light. For LED light irradiation function, the device produces light in the red-light region of the spectrum (633±10nm), combination of IR and Red light (830nm±10nm & 633 ± 10 nm), or in the blue light region of the spectrum (415±10nm).
The TheraFace Mask device is shaped like a human face and is designed to be "one size fits most." There are two physical buttons located on the mask; one controls the LED function and the other controls the vibration. The 648 LEDs in the device are powered by two internal lithium-ion rechargeable batteries which are charged via USB Type C or A cable with power adaptor.
Red light mode: In Red light irradiation mode, the device utilizes Light Emitting Diodes to emit The output is one wavelength with a narrow spectral bandwidth in 633±10nm. red light. lt provides narrow bands of red-light energy to facial skin and is intended to treat full-face wrinkles.
Blue light mode: In blue light irradiation mode, the device utilizes Light Emitting Diodes to emit blue light. The output is one wavelength with a narrow spectral bandwidth in 415±10nm. It provides narrow bands of blue light energy to facial skin and is intended to treat mild to moderate inflammatory acne.
Red+ IR mode: When the device is operated in the red combined with infrared light mode, it emits LED light in the RED (633 nm±10nm) and IR (830 nm±10nm) spectrum on facial skin. lt is intended to treat full face wrinkles.
Vibration mode: The device can drive 8 vibration motors around the eyes and 9 vibration motors on the top and back of the head in different vibration speeds. There are 3 different vibration patterns; continuous mode, breathe mode, and wave mode. Vibration is included for general relaxation purposes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
full face, facial skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
A series of studies were completed to demonstrate the substantial equivalence of TheraFace Mask to the predicate/reference devices. All testing was conducted in accordance with and in conformance to applicable device regulations and guidance. Results of all testing demonstrate the device is non-toxic, is comparable to other currently marketed devices and is substantially equivalent to legally marketed predicates and included:
Biocompatibility
ISO 10993-5:2009, biological evaluation of medical devices - part 5: tests for In Vitro Cytotoxicity Test (CSTBB2022120087)
ISO 10993-10 :2010, Biological evaluation of medical devices - part 10: Skin Sensitization Test (CSTBB2022120404R1)
ISO 10993-11:2017, Biological evaluation of medical devices - Part 11:
- Acute Systemic Toxicity Test (CSTBB2022110675R1)
- Material-mediated Pyrogens Test (CSTBB2022120016R1)
ISO 10993-23:2021, Biological evaluation of medical devices - Part 23: Tests for Intradermal Reactivity (CSTBB2022110602R1
Electrical Safety and Electromagnetic Compatibility
IEC60601-1:2005 +CORR.1:2006+ CORR.2:2007+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (CHTSM22120256)
IEC 60601-1-2: 2014-02, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - collateral standard: Electromagnetic Compatibility. (CHTEM22120257)
IEC 60601-1-11 :2015, Medical electrical equipment -- part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home health care environment. (CHTSM22120260)
IEC 60601-2-57: 2011 for use in conjunction with IEC 60601-1:2005, Medical electrical equipment - Part 2: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use. (CHTSM22120259)
IEC 62471:2006, Photobiological safety of lamps and lamp systems. (CHTSM22120258)
IEC 62133 Edition 2.0 2012-12, 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 (PNC221027191 01001)
PERFORMANCE TESTING BENCH Light power density test report (FP221125050384)
Usability Study Report DES-013.3
Device Temperature Range Testing Final Report Apr 16, 2023
Cleaning and Disinfection Testing
AAMI TIR30:2011/(R)2016 - A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices: Tests for Cleaning (CSTBB22100180)
AAMI TIR12:2010-Designing, testing and labeling reusable medical devices for reprocessing in health care facilities-Section 5: Tests for Disinfection (CSTBB22100180)
(9) PERFORMANCE TESTING CLINICAL
There were no clinical studies performed.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 9, 2023
Therabody, Inc. % Thomas Padula Vice President Regulatory Compliance Schiff & Company, Inc. 583 Mountain Avenue North Caldwell, New Jersey 07006
Re: K230293
Trade/Device Name: TheraFace Mask 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: May 10, 2023 Received: May 10, 2023
Dear Thomas Padula:
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.
1
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 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.
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
Submission Number (if known)
Device Name
TheraFace Mask
Indications for Use (Describe)
- · Red Light is intended to treat full face wrinkles
- · Blue Light is intended to treat mild to moderate inflammatory acne
- · Red + Infrared Light is intended to treat full face wrinkles
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 (as required by 807.92)
K230293
Date: June 6, 2023 (1) SUBMITTER: THERABODY, Inc. 6100 Wilshire Blvd Suite 200 Los Angeles, CA 90048 Registration Number: 3012386142 FEI Number: 3012386142 Contact person: CJ Frederick, III Telephone: 484-888-1290 Email: cifrederick@therabodycorp.com Date prepared: May 18, 2023
Application Correspondent:
Contact Person: Thomas Padula Company: Schiff & Company, Inc. Address: 583 Mountain Avenue, North Caldwell, NJ 07006 Tel: 201-317-8810 Email: thomaspadula@schiffandcompany.com
(2) DEVICE NAME:
Trade Name: TheraFace Mask Common Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Classification Name: Light Based Over the Counter Wrinkle Reduction Device Classification: Class II Review Panel: General & Plastic Surgery Regulation Number: 21 CFR 878.4810 Product Code: OHS, OLP
- (3) PREDICATE DEVICE(S): Substantial equivalence is based on following legally marketed devices.
| Device Name and
Model | MZ Skin LightMAX
Supercharged LED Mask 2.0 | LED Therapy Device | RED Light Device |
|--------------------------|-----------------------------------------------|----------------------------|-------------------------------|
| 510(k) Number | K213184 (Primary Predicate
device) | K192295 (Predicate device) | K162489 (Reference
device) |
| Product Code | OHS, OLP | OHS, OLP | OHS |
| Regulation Number | 878.4810 | 878.4810 | 878.4810 |
| Regulation Class | II | II | II |
4
(4) DESCRIPTION OF THE DEVICE:
The TheraFace Mask device is a lightweight device which uses specified wavelengths of LED light. For LED light irradiation function, the device produces light in the red-light region of the spectrum (633±10nm), combination of IR and Red light (830nm±10nm & 633 ± 10 nm), or in the blue light region of the spectrum (415±10nm).
The TheraFace Mask device is shaped like a human face and is designed to be "one size fits most." There are two physical buttons located on the mask; one controls the LED function and the other controls the vibration. The 648 LEDs in the device are powered by two internal lithium-ion rechargeable batteries which are charged via USB Type C or A cable with power adaptor.
Red light mode: In Red light irradiation mode, the device utilizes Light Emitting Diodes to emit The output is one wavelength with a narrow spectral bandwidth in 633±10nm. red light. lt provides narrow bands of red-light energy to facial skin and is intended to treat full-face wrinkles.
Blue light mode: In blue light irradiation mode, the device utilizes Light Emitting Diodes to emit blue light. The output is one wavelength with a narrow spectral bandwidth in 415±10nm. It provides narrow bands of blue light energy to facial skin and is intended to treat mild to moderate inflammatory acne.
Red+ IR mode: When the device is operated in the red combined with infrared light mode, it emits LED light in the RED (633 nm±10nm) and IR (830 nm±10nm) spectrum on facial skin. lt is intended to treat full face wrinkles.
Vibration mode: The device can drive 8 vibration motors around the eyes and 9 vibration motors on the top and back of the head in different vibration speeds. There are 3 different vibration patterns; continuous mode, breathe mode, and wave mode. Vibration is included for general relaxation purposes.
(5) INDICATIONS FOR USE:
The device can work in multiple modes as described below, with the corresponding indications for use:
- •Red Light is intended to treat full face wrinkles
- ·Blue Light is intended to treat mild to moderate inflammatory acne
- ·Red + Infrared Light is intended to treat full face wrinkles
- (6) COMPARISON WITH PREDICATE DEVICES: Following table is a comparison of TheraFace Mask and predicate/reference devices.
TheraFace Mask is substantially equivalent in terms of the technological characteristics,
5
features, specifications, materials, mode of operation and indications for use, to MZ Skin LightMAX Supercharged LED Mask 2.0 K213184 (Primary Predicate Device), LED Therapy Device, K192295 (Secondary Predicate device), and RED Light Device K162489 (Reference device), cleared for marketing under 510(K).
Comparison in Detail(s):
Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Primary Predicate Device
K213184 | Secondary Predicate Device
K192295 | Reference Device
K162489 | Remark |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | OLP, OHS | OLP, OHS | OHS, OLP | OHS | (Please provide Justification for differences) |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Class | Class 2 | Class 2 | Class 2 | Class 2 | SAME |
| Indication for Use | •Red Light is intended to treat full face wrinkles
•Blue Light is intended to treat mild to moderate inflammatory acne
•Red + Infrared Light is intended to treat full face wrinkles | The MZ Skin LightMAX Supercharged LED Mask 2.0 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 MZ Skin LightMAX Supercharged LED Mask 2.0 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 red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne. The device is indicated for adults only. | The RED Light Device is an OTC device indicated to emit energy in the red and IR region of the spectrum for use in the dermatology for the treatment of periorbital wrinkles. | No differences in Indications for Use for Red Light, Blue Light or Red Light + Near Infra-Red Light. Of note is that while the primary predicate uses the term "acne vulgaris," this is a form of inflammatory acne and therefore the IFU for blue light are identical for all devices. |
Table 1 General Comparison
6
| Prescription/OTC | OTC | OTC | OTC | OTC | SAME |
|---|---|---|---|---|---|
| ------------------ | ----- | ----- | ----- | ----- | ------ |
Table 2 Performance Comparison
| Item | Proposed Device | Primary
Predicate
Device K213184 | Secondary
Predicate Device
K192295 | Reference
Device K162489 | Remark |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power Source | 5-15V DC 2.5A max
powered by 2 Li-Ion
Batteries 3.7V
1500mAh) is charged
via Universal USB
charger cord or fast
charger adaptor | Lithium-ion
battery powered
controller.
Power Supply
charges the
batter by direct
plug-in adapter
(2 or 3 pin input
socket and wall
plug. Power
cable is
connected to the
controller by a
standard micro-
USB A-C
Connector. | 5.V DC 2.0 A
Powered by direct
plug-in adapter:
Input 100-240V
AC, 50/60 Hz, 0.5A
Max., Output 5.0V
DC 2.0A | Adaptor:
100~240V AC
50/60Hz
Lithium Battery: 2
x 3.7V | Note 1 |
| Software/Firm
ware/Microprocessor
Control? | Yes | Yes | Yes | Yes | SAME |
| Power
(mW/cm²) | Red: 73 $\pm$ 5mW/cm²
Blue: 64 $\pm$ 5mW/cm²
Red+IR: 73 $\pm$ 5mW/cm²/
55 $\pm$ 5mW/cm² | Blue/Red:
44mW/cm²
Red/NIR:
29mW/cm² | Red light: 80 $\pm$ 10%
Blue light: 50 $\pm$ 10% | 125mW/cm²
70mW/cm²
(633nm); 55
mW/cm²
(830nm) | Reference device
has the
same/similar
power density as
proposed device
and has been
cleared therefore
proposed device is
safe and effective. |
| Dose (J/cm²) | Red 13.14 +/-0.9 J/cm²
Blue: 11.52 +/-0.9 J/cm²
Red+IR: 11.52 +/- 0.9
J/cm² | Red 9.6J/cm² &
11J/cm²
Blue: 16.8J/cm²
NIR: 7J/cm² | Not available | Not available | |
| Wavelength | Red: 633 $\pm$ 10nm
Blue: 415 $\pm$ 10nm
Red+IR:633nm $\pm$ 10nm/830 $\pm$ 10 nm | Blue light:
415nm $\pm$ 10nm
Red light: 630nm $\pm$ 10nm
NIR: 830+10nm | Blue light: 415nm
$\pm$ 5nm
Red light: 630nm
$\pm$ 5nm | Red: 633 +5nm
IR: 830 +5nm | Note 2
SAME for Blue
Light & Red+IR
(aka IR or NIR)
Light |
7
| Treatment
Duration | LED: 3 minutes each
light mode for a total of 9
minutes per treatment,
recommended to use 2
to 5 times per week.
Vibration: accompanies
LED treatments or can
be used without LED's
active. 3 vibration
patterns, 5 minutes each,
for a total of 15 minutes.
During blue light
treatment mode,
vibration is not active
around the eyes.
Vibration is included for a
more relaxing
experience. | 10 minutes per
treatment.
Acne: 4x
Weekly, 6 weeks
Wrinkles: 5x
Weekly, 6 weeks | 3-5 minutes each
time, twice
a week | For the first
month (4 weeks),
treatment should
be performed 3
times a week for
15-20 minutes
each time (5-7
minutes on each
treatment zone). | Note 3 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Main Materials | PC+ABS | Silicone | PC+ABS | ABS + Stainless
Steel | SAME and Similar |
Table 3 Safety Comparison
| Item | Proposed Device | Primary Predicate
Device #1
K213184 | Secondary Predicate
Device
K192295 | Reference Device
K162489 | Remark |
|---------------------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------|--------|
| Electrical Safety | Complies with IEC
60601-1,
IEC 60601-1-11 | Comply with IEC
60601-1,
IEC 60601-1-11 | Comply with IEC
60601-1,
IEC 60601-1-11 | Comply with IEC
60601-1, IEC 60601-
1-11, IEC60601-2-57 | SAME |
| Photobiological
Safety | Complies with IEC
62471
Complies with IEC
60601-2-57 | Comply with IEC
62471 | Comply with IEC
62471 | IEC 62471 | SAME |
| EMC | Complies with IEC
60601-1-2 | Comply with IEC
60601-1-2 | Comply with IEC
60601-1-2 | IEC 60601-1-2 | SAME |
| Biocompatibility | Complies with ISO
10993-1,
ISO 10993-5 and
ISO 10993-10
ISO 10993-11
ISO 10993-23 | Comply with ISO
10993-1,
ISO 10993-5 and
ISO 10993-10 | Comply with ISO
10993-1,
ISO 10993-5 and ISO
10993-10 | Comply with ISO
10993-1 | SAME |
| Label and | Conforms to FDA | Conforms to FDA | Conforms to FDA | Conforms to FDA | SAME |
8
| Labeling | Regulatory
Requirements | Regulatory
Requirements | Regulatory
Requirements | Regulatory
Requirements | |
| ---------- | ---------------------------- | ---------------------------- | ---------------------------- | ---------------------------- | -- |
|---|
Difference Analysis:
(Please explain any item that is not "SAME")
Note 1: The proposed device is battery powered, similar to the reference devices. The battery in the proposed device supports a longer battery life as well as fast charging. This does not affect the safety, effectiveness, or indications for use of the proposed device.
Note 2:
The target LED wavelength and variance range of the proposed, predicate, and reference device (variance ranges not provided) differ by just 3nm for Red Light at the high and low end of the output spectrum, with the proposed device being slightly higher. This represents a very minor difference and not one to affect equivalence. Furthermore, the proposed device has passed testing according to IEC60601-2-57. There is no effect on safety, effectiveness, or intended use of the proposed device.
Note 3:
Predicate device and reference devices do not have vibration.
Proposed device is used for 7 less minutes per light treatment compared to the predicate device and is either identical or less than reference devices with respect to treatment time per light mode.
Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicates K213184 and K192295 and Reference Device K162489.
(7) PERFORMANCE STANDARDS APPLIED:
A series of studies were completed to demonstrate the substantial equivalence of TheraFace Mask to the predicate/reference devices. All testing was conducted in accordance with and in conformance to applicable device regulations and guidance. Results of all testing demonstrate the device is non-toxic, is comparable to other currently marketed devices and is substantially equivalent to legally marketed predicates and included:
Biocompatibility
ISO 10993-5:2009, biological evaluation of medical devices - part 5: tests for In Vitro Cytotoxicity Test
(CSTBB2022120087)
ISO 10993-10 :2010, Biological evaluation of medical devices - part 10: Skin Sensitization Test (CSTBB2022120404R1)
9
ISO 10993-11:2017, Biological evaluation of medical devices - Part 11:
- Acute Systemic Toxicity Test (CSTBB2022110675R1)
- Material-mediated Pyrogens Test (CSTBB2022120016R1)
ISO 10993-23:2021, Biological evaluation of medical devices - Part 23: Tests for Intradermal Reactivity
(CSTBB2022110602R1
Electrical Safety and Electromagnetic Compatibility
IEC60601-1:2005 +CORR.1:2006+ CORR.2:2007+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (CHTSM22120256)
IEC 60601-1-2: 2014-02, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - collateral standard: Electromagnetic Compatibility. (CHTEM22120257)
IEC 60601-1-11 :2015, Medical electrical equipment -- part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home health care environment. (CHTSM22120260)
IEC 60601-2-57: 2011 for use in conjunction with IEC 60601-1:2005, Medical electrical equipment - Part 2: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use. (CHTSM22120259)
IEC 62471:2006, Photobiological safety of lamps and lamp systems. (CHTSM22120258)
IEC 62133 Edition 2.0 2012-12, 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 (PNC221027191 01001)
(8) PERFORMANCE TESTING BENCH Light power density test report (FP221125050384)
10
Usability Study Report DES-013.3
Device Temperature Range Testing Final Report Apr 16, 2023
Cleaning and Disinfection Testing
AAMI TIR30:2011/(R)2016 - A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices: Tests for Cleaning (CSTBB22100180)
AAMI TIR12:2010-Designing, testing and labeling reusable medical devices for reprocessing in health care facilities-Section 5: Tests for Disinfection (CSTBB22100180)
(9) PERFORMANCE TESTING CLINICAL
There were no clinical studies performed.
(10) CONCLUSION: TheraFace Mask has the same indications for use and technology characteristics as the predicate/reference devices. TTheraFace Mask is as safe, as effective, and performs as well as the predicate/reference devices.