(72 days)
No
The description focuses on hardware components (LEDs, Peltiers, fans, remote controller) and pre-programmed routines. There is no mention of adaptive learning, data processing for personalized treatment, or any other characteristic typically associated with AI/ML.
Yes
The device is intended to treat mild-to-moderate inflammatory acne, which constitutes a medical treatment. Under-eye cooling function to refresh/invigorate/soothe the skin supports a therapeutic purpose.
No
Explanation: The device description and intended use clearly state that the CryoGlow LED mask is an "over-the-counter (OTC) beauty device" intended to emit light for the "treatment of mild-to-moderate inflammatory acne" and for "lines and wrinkles." It is a therapeutic device, not a diagnostic one, as it does not gather or analyze data to identify a condition or disease.
No
The device description clearly outlines physical hardware components including a molded plastic mask, LEDs, Peltiers, fans, chill pads, a remote controller, and a charging system. It also mentions electrical, mechanical, optical, and thermal safety testing, which are associated with hardware devices.
Based on the provided information, the CryoGlow LED mask is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- CryoGlow's Function: The CryoGlow mask applies light energy directly to the skin for therapeutic purposes (treating lines, wrinkles, and acne) and provides cooling for comfort. It does not analyze any biological samples.
Therefore, the CryoGlow LED mask falls under the category of a therapeutic or cosmetic device, not an IVD.
N/A
Intended Use / Indications for Use
The CryoGlow LED mask emits energy in the red and infrared light spectrum for the lines and wrinkles and in the red, blue, and infrared light spectrum for the treatment of mild-to-moderate inflammatory acne.
Product codes (comma separated list FDA assigned to the subject device)
OHS, OLP
Device Description
The CryoGlow mask is an over-the-counter (OTC) beauty device intended to emit energy in the red and infrared spectrum to treat fine lines and wrinkles, and in the red, blue, and infrared light spectrum to treat mild-to-moderate inflammatory acne. It is made of molded plastic and is designed to be worn over the face. The device incorporates 480 LEDs (160 tri-wick packages) that emit combinations of red, blue, and infrared light depending on the skin routine chosen. The mask also incorporates under-eye cooling technology. Using the attached remote controller and graphical user interface, users may choose from three skin care routines: Better Aging (red and infrared light), Skin Clearing (blue, red and infrared light), and Skin Sustain (blue and red light). During each routine, a combination of red, blue, and infrared light is emitted for a prescribed amount of time.
The CryoGlow mask also incorporates an under-eye cooling function. Peltiers and fans are used to cool the built-in chill pads (cool sinks) that rest on the surface of the skin under the eyes. The cooling feature turns on automatically with each skin routine, but users may turn off the undereye cooling function during a skin care routine or run a stand-alone under-eye cooling session. The cooling function is intended to refresh/invigorate/soothe the skin. Optional clip-on chill pads are provided with the device to help achieve the proper fit.
Silicone eye shields are built into the design of the mask to help protect the user's eyes from the LED light during a treatment routine. Other built-in safety features include an automatic shut off and auto-dimming feature where the LED lights dim when the mask is away from the user's face. Electrical, mechanical, optical, and thermal safety testing has been conducted to support the safety and effectiveness of the mask.
The CryoGlow mask must be charged prior to use and is provided with a USB-A to USB-C charging cord and USB-A charging block. An optional charging stand is provided separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face / Under-eye
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)
Non-Clinical Testing:
- Product Safety and EMC performance was tested against IEC 60601-1:2005/AMD2:2020, IEC 60601-1-2:2014 +AMD1:2020, IEC 60601-1-11:2015/AMD1:2020, and IEC 62471:2006.
- Bench testing was conducted to verify the peak wavelength of each light spectrum and to demonstrate that the power/power density of the CryoGlow LEDs is equivalent to that of the predicate device.
- Total energy (amount of light delivered to the skin) for each CryoGlow mode (Skin Sustain, Better Aging, and Skin Clearing) was calculated and determined to be substantially equivalent to the total energy by the TheraFace device.
- The median distance between the LEDs in the CryoGlow device was calculated and determined to be essentially equivalent to that of the TheraFace device, confirming uniform light distribution.
- Design Verification and Validation Testing was conducted to confirm that CryoGlow meets the design requirements and performs as intended.
- A human factors/usability study was conducted to demonstrate that CryoGlow can be used safely and effectively by its intended users, for the intended use of the device, and in the intended use environment. FDA's guidance document "Applying Human Factors and Usability Engineering to Medical Devices" (February 3, 2016) was considered.
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.
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November 27, 2024
SharkNinja Operating, LLC % Lynette Zentgraft Senior Advisor Covington & Burling, LLP One CityCenter 850 Tenth Street, NW Washington, District of Columbia 20001
Re: K242796
Trade/Device Name: CryoGlow (FW3XXXX) 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: September 16, 2024 Received: September 16, 2024
Dear Lynette Zentgraft:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Image /page/2/Picture/3 description: The image shows a digital signature. The name "Yan Fu -S" is displayed in a large font on the left side of the image. On the right side, the text "Digitally signed by Yan Fu -S" is present, along with the date and timestamp "Date: 2024.11.27 09:58:09 -05'00'".
for Tanisha Hithe
Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical & Infection Control Devices, Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242796
Device Name CryoGlow (FW3XXXX)
Indications for Use (Describe)
The CryoGlow LED mask emits energy in the red and infrared light spectrum for the lines and wrinkles and in the red, blue, and infrared light spectrum for the treatment of mild-to-moderate inflammatory acne.
Type of Use (Select one or both, as applicable)
| Exemption Use (Part 1, 321 CMR 2.01, Category D) | |
|---|---|
| One-Time Event Use (321 CMR 2.01, Category G) |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary K242796
| Date: | November 13, 2024 |
|---|---|
| Submitter: | SharkNinja Operating, LLC |
| 89 A Street, Suite 100 | |
| Needham, MA 02494 | |
| Contact person: | Alyssa Aquino |
| Email: AAquino@sharkninja.com | |
| Tel: 617-546-5768 | |
| Application | |
| Correspondent: | Lynette Zentgraft |
| Covington & Burling, LLP | |
| Email: lzentgraft@cov.com | |
| Tel: 202-662-5404 | |
| Device Trade | |
| Name: | CryoGlow LED mask (FW3XXXX) |
| 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 |
| Predicate | |
| Device: | TheraFace |
| K230293 | |
| Product codes OHS, OLP | |
| 21 CFR 878.4810 | |
| Class II | |
| Reference | |
| Device: | MZ Skin LightMAX Supercharged LED Mask 2.0 |
| K213184 |
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Product codes OHS, OLP 23 CFR 878.4810 Class II
Indications for Use
The CryoGlow LED mask emits energy in the red and infrared light spectrum for the treatment of fine lines and wrinkles and in the red, blue and infrared light spectrum for the treatment of mild-to-moderate inflammatory acne.
Device Description
The CryoGlow mask is an over-the-counter (OTC) beauty device intended to emit energy in the red and infrared spectrum to treat fine lines and wrinkles, and in the red, blue, and infrared light spectrum to treat mild-to-moderate inflammatory acne. It is made of molded plastic and is designed to be worn over the face. The device incorporates 480 LEDs (160 tri-wick packages) that emit combinations of red, blue, and infrared light depending on the skin routine chosen. The mask also incorporates under-eye cooling technology. Using the attached remote controller and graphical user interface, users may choose from three skin care routines: Better Aging (red and infrared light), Skin Clearing (blue, red and infrared light), and Skin Sustain (blue and red light). During each routine, a combination of red, blue, and infrared light is emitted for a prescribed amount of time.
The CryoGlow mask also incorporates an under-eye cooling function. Peltiers and fans are used to cool the built-in chill pads (cool sinks) that rest on the surface of the skin under the eyes. The cooling feature turns on automatically with each skin routine, but users may turn off the undereye cooling function during a skin care routine or run a stand-alone under-eye cooling session. The cooling function is intended to refresh/invigorate/soothe the skin. Optional clip-on chill pads are provided with the device to help achieve the proper fit.
Silicone eye shields are built into the design of the mask to help protect the user's eyes from the LED light during a treatment routine. Other built-in safety features include an automatic shut off and auto-dimming feature where the LED lights dim when the mask is away from the user's face. Electrical, mechanical, optical, and thermal safety testing has been conducted to support the safety and effectiveness of the mask.
The CryoGlow mask must be charged prior to use and is provided with a USB-A to USB-C charging cord and USB-A charging block. An optional charging stand is provided separately.
Substantial Equivalence
Substantial equivalence is based on comparison to the predicate TheraFace device and reference MZ Skin LightMAX reference device.
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| Elements of
Comparison | Proposed Device
CryoGlow | Predicate Device
TheraFace | Reference Device
MZ Skin
LightMAX
Supercharged
LED Mask 2.0 | Comment |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| 510(k)Submission
Number | | K230293 | K213184 | |
| Trade Name | CryoGlow | TheraFace | MZ Skin
LightMAX
Supercharged LED
Mask 2.0 | |
| Product Code | OLP, OHS | OLP, OHS | OLP, OHS | Same |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Class | Class 2 | Class 2 | Class 2 | Same |
| Indication for Use | The CryoGlow LED
mask emits energy in
the red and infrared
light spectrum for the
treatment of fine lines
and wrinkles and in the
red, blue and infrared
light spectrum for the
treatment of mild-to-
moderate inflammatory
acne. | Red light is
intended to treat
full face wrinkles
Blue light is
intended to treat
mild to moderate
inflammatory acne
Red and 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. | Similar to the
predicate
device and
reference
device. |
| Prescription/OTC | OTC | OTC | OTC | Same |
| Power Source | 2 Li-Ion Batteries 3.6V,
2350 mAh total, | 5-15V DC 2.5A
max powered by 2 | Rechargeable Li-
Ion polymer battery | Similar |
| Software/Firmware/Microprocessor
Control | USB-C charging cord
to USB-A charging
block | 3.7V 1500mAh),
charged via
Universal USB
charger cord or fast
charger adaptor | | |
| | Yes | Yes | Yes | Same |
| Power (mW/cm²) | Skin Sustain:
Blue 59.8 ± 7 mW/cm²,
Red 17.0 ± 5mW/cm²,
IR 51.2 ± 5 mW/cm²
Total mode = 128 mW/cm²
Skin Clearing [Step 1]:
Blue 64 ± 8 mW/cm²,
IR 64.0 ± 5 mW/cm²
Total mode =128 mW/cm²
Skin Clearing [Step 2]:
Blue 55 ± 6 mW/cm²,
Red 73 mW/cm²
Total mode =128 mW/cm²
Skin Clearing [Step 3]:
Red 73 mW/cm², IR 55 ± 5mW/cm²,
Total mode =128 mW/cm²
Better Aging:
Red 64 ± 5mW/cm², IR 64 ± 5 mW/cm²
Total mode = 128 mW/cm² | Modes:
Red: 73 ± 5mW/cm²
Blue: 64 ± 5mW/cm²
Red+IR: 73 ± 5mW/cm² / 55 ± 5 mW/cm² =
128mW/cm² | Acne:
Blue 28mW/cm²
Red 16 mW/cm²
Total = 44 mW/cm²
Wrinkles:
Red 19 mW/cm²
NIR 11 mW/cm²
Total = 29 mW/cm² | Similar to the
predicate
device |
| Total Dose for all
LEDs | Skin Sustain: | Blue = $137.4 J/cm^2$ | Acne: | Similar to the
predicate
device. |
| | Total Blue dose =
$137.4 J/cm^2$ | Red = $156.7 J/cm^2$ | Blue $16.8 J/cm^2$ | |
| | Total Red/IR = $156.7 J/cm^2$ | Red+IR = $274.7 J/cm^2$ | Red $9.6 J/cm^2$ | |
| | Skin Clearing [Step 1] | | Wrinkles: | |
| | Total Blue dose = $27.1 J/cm^2$ | Total/cumulative
dose (modes are run
back-to-back): | Red $11 J/cm^2$ | |
| | Total Red/IR = $27.1 J/cm^2$ | Blue = $137.4 J/cm^2$ | NIR $7 J/cm^2$ | |
| | Skin Clearing [Step 2] | Red & IR = $431.4 J/cm^2$ | | |
| | Total Blue dose = $110.2 J/cm^2$ | Total = $568.8 J/cm^2$ | | |
| | Total Red/IR = $146.2 J/cm^2$ | | | |
| | Skin Clearing [Step 3] | | | |
| | Total Red/IR = $258.1 J/cm^2$ | | | |
| | Skin Clearing Total | | | |
| | Total Blue dose = $137.4 J/cm^2$ | | | |
| | Total Red/IR = $431.4 J/cm^2$ | | | |
| | Better Aging | | | |
| | Total Red/IR = $431.4 J/cm^2$ | | | |
| Wavelength | Red: 630 ±10nm | Red: 633 ±10nm | Red: 630 ±10nm | Same |
| | Blue: 415 ±10nm | Blue: 415 ±10nm | Blue: 415 ±10nm | |
| | IR: 830 ± 10 nm | Red+IR:633nm
±10nm/830 ± 10
nm | NIR: 833 ±10nm | |
| Irradiance Source | LEDs | LEDs | LED | Same |
| Total Number of
LEDS | 480 (160 tri-wick
packages) | 648 (216 tri-wick
packages) | unknown | Similar to the
predicate
device (the
size of the of
LEDs are the
same) |
| Treatment Duration | | | | |
| | Skin Sustain: 4.3 min
(daily after 8 weeks) | LED: 3 minutes each light mode for a total of 9 minutes per treatment, recommended to use 2 to 5 times per week. | 10 mins (may be stopped at any time)
Acne: 4 x weeks, 6 weeks
Wrinkles: 5 x weeks, 6 weeks | Similar to both the predicate and reference devices. |
| | Skin Clearing: 8.4 min
(daily for at least 8 weeks) | 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. | | |
| | Better Aging: 6.4 min
(daily for at least 8 weeks) | | | |
| | Under-eye cooling: may be used with LED treatments or can be used without LEDs active. Variable cooling settings are available and may be adjusted by the user. Cooling is intended for refreshing/invigorating/soothing the skin only. | | | |
| Main Materials | ABS + MABS | PC + ABS | Methyl vinyl silicone rubber | Similar |
| Tested for Electrical Safety? | Yes
Tested against IEC 60601-1 (see cover note to electrical, mechanical, and thermal testing section) | Yes
Complies with IEC 60601-1 | Yes
Complies with IEC 60601-1 | Same |
| Tested for Photobiological Safety? | Yes
Complies with IEC 62471
Complies with IEC 60601-2-83 | Yes
Complies with IEC 62471
Complies with IEC 60601-2-57 | Yes
Complies with IEC 62471 | Same |
| Tested for EMC? | Yes
Complies with IEC 60601-1-2 | Yes
Complies with IEC 60601-1-2 | Yes
Complies with IEC 60601-1-2 | Same |
| Tested for
Biocompatibility? | Yes | Yes | Yes | Same |
| | Complies with: | Complies with: | Complies with: | |
| | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | |
| | ISO 10993-5 | ISO 10993-5 | ISO 10993-5 | |
| | ISO 10993-10 | ISO 10993-10 | ISO 10993-10 | |
| | ISO 10993-23 | ISO 10993-11 | | |
| | | ISO 10993-23 | | |
7
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9
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The CryoGlow, TheraFace predicate device and MZ Skin LightMAX reference device, use light emitted from LEDs in the blue, red, and infrared spectrum to treat facial wrinkles and mild-tomoderate inflammatory acne. Both the CryoGlow and predicate device use red and infrared light to treat facial wrinkles. CryoGlow emits light in the blue, red, and infrared spectrum to treat mild-to-moderate acne, which is equivalent to the reference MZ Skin LightMAX reference device (for purposes of the CryoGlow device, red and infrared light are considered equal).
Both the CryoGlow and predicate device are powered by 2 Li-Ion battery cells and provided with a charging cord and USB charging block. Differences between the batteries, charging cord, and charging block are minor and will not affect safety or effectiveness.
Although the predicate device includes more LEDs, the individual LEDs is the same as those used in the predicate device. Testing demonstrates that the LED distance from the face is such that the CrvoGlow LED beams overlap by the time thev reach the skin. uniformly distributing light. Additionally, the calculated median distance between the LEDs included in the CryoGlow is essentially equivalent to the calculated median distance between the LEDs included in the predicate device. These results show that, despite the differences in the number of LEDs. the distribution of light over the treatment area from the CryoGlow mask is substantially equivalent to the distribution of light from the TheraFace mask.
The treatment times and routines offered by the CryoGlow device differ from those of the predicate TheraFace device. For purposes of demonstrating substantial equivalence, the total energy delivered from the device into the face is the critical parameter, which takes into consideration multiple parameters of the LEDs, including wavelength, power/power density, treatment time, treatment area, and the number of LEDs. Research and technical analyses demonstrate that the power density for the predicate TheraFace device and CryoGlow are equivalent. Additional research supports that, when calculating the overall dose for CryoGlow, red and infrared light are considered equal. Using the treatment times for each mode, the calculated overall dose provided by CryoGlow is equivalent to the total/cumulative dose provided by the predicate TheraFace device when used to treat both facial wrinkles and mild-tomoderate inflammatory acne. Additionally, the power mode densities of the individual red, infrared, and blue LEDs of CryoGlow do not exceed those of the TheraFace device.
The CryoGlow treatment times are slightly different than those of the predicate; however, as described above, the total dose provided by the device in each mode (Skin Sustain, Better Aging, and Skin Clearing) is the same as that provided by the predicate device.
Although there are differences between the number of LEDs, power/power density, modes, and treatment times between the CryoGlow and predicate device, the total energy delivered to the
11
face from the CrvoGlow device is substantially equivalent to that delivered by the predicate TheraFace device. Therefore, these differences do not raise new questions of safety or effectiveness as compared to the predicate device.
There are minor differences in the materials of the CryoGlow device as compared to the predicate TheraFace device. However, both devices are made of molded plastic, so this difference does not raise new questions of safety or effectiveness.
The predicate TheraFace device includes vibration, whereas the CryoGlow does not. The CryoGlow includes under-eye cooling technology, which the predicate does not. The vibration function of the predicate does not impact the safety or effectiveness of the device for the treatment of wrinkles and acne; rather, it is intended for relaxation purposes. Similarly, the under eye cooling feature of CryoGlow is for purposes of refreshing/invigorating/soothing the skin only and does not impact the device's safety or effectiveness in treating fine lines, wrinkles or acne. Therefore, this difference does not raise new questions of safety or effectiveness.
Non-Clinical Testing
To establish substantial equivalence to the predicate device, the CryoGlow was tested against the applicable standards for electrical safety, EMC, and biocompatibility, as listed in the Substantial Equivalence Comparison Table above.
Product Safety and EMC performance was tested against the following industry standards:
- IEC 60601-1:2005/AMD2:2020 ●
- IEC 60601-1-2:2014 +AMD1:2020 ●
- IEC 60601-1-11:2015/AMD1:2020 ●
- IEC 62471:2006 .
Bench testing was conducted to verify the peak wavelength of each light spectrum and to demonstrate that the power power density of the CryoGlow LEDs is equivalent to that of the predicate device. Using the power/power density values, the total energy (amount of light delivered to the skin) for each CryoGlow mode (Skin Sustain, Better Aging, and Skin Clearing) was calculated and determined to be substantially equivalent to the total energy by the TheraFace device. The median distance between the LEDs in the CryoGlow device was also calculated, and was determined to be essentially equivalent to that of the TheraFace device. This, along with additional bench testing, confirmed that the distribution of light from the CryoGlow mask is uniform and is substantially equivalent to that of the predicate TheraFace device, despite the difference in the number of LEDs.
Additionally, Design Verification and Validation Testing was conducted to confirm that CrvoGlow meets the design requirements and performs as intended. A human factors/usability study was conducted to demonstrate that CryoGlow can be used safely and effectively by its intended users, for the intended use of the device, and in the intended use environment. FDA's guidance document "Applying Human Factors and Usability Engineering to Medical Devices" (February 3, 2016) was considered when conducting this testing.
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Conclusion
Both the CryoGlow and predicate device have the same intended use. The technological differences between the CryoGlow mask and the predicate device do not raise new questions of safety or effectiveness. Therefore, the CryoGlow is substantially equivalent to the predicate TheraFace device.