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.

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.

AI/ML Overview

Based on the provided text, the device in question, CryoGlow, is an LED mask that emits light in the red, blue, and infrared spectrum for the treatment of fine lines and wrinkles and mild-to-moderate inflammatory acne. The submission is a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device (TheraFace, K230293) and a reference device (MZ Skin LightMAX Supercharged LED Mask 2.0, K213184), rather than proving the device meets specific acceptance criteria through an independent clinical study that establishes de novo performance.

However, the document does describe how the CryoGlow device's performance was compared to its predicate device to demonstrate substantial equivalence, which implicitly serves as the "acceptance criteria" for this 510(k) submission.

Here's an analysis of the provided information concerning "acceptance criteria" and the "study that proves the device meets the acceptance criteria" in the context of a 510(k):

Acceptance Criteria and Reported Device Performance (Implicit from Substantial Equivalence Comparison)

Since this is a 510(k) submission, the "acceptance criteria" is primarily the demonstration of substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device. The performance comparison between CryoGlow and its predicate/reference devices forms the basis of meeting this "acceptance criterion."

Here's an interpretation of the performance comparisons presented in the document, framed as "acceptance criteria" (implicitly similar to predicate/reference) and "reported performance."

Acceptance Criteria (Similar to Predicate/Reference)	Reported Device Performance (CryoGlow)
Indications for Use: Treat fine lines/wrinkles and mild-to-moderate inflammatory acne using red, blue, and infrared light.	Emits energy in red and infrared light spectrum for fine lines and wrinkles. Emits red, blue, and infrared light spectrum for mild-to-moderate inflammatory acne. (Similar to predicate/reference, considering red and infrared light for CryoGlow equivalent to predicate's red and IR, and blue, red, IR for acne equivalent.)
Power (Irradiance) Densities: Similar to predicate (e.g., TheraFace: Red: 73 ± 5mW/cm², Blue: 64 ± 5mW/cm², Red+IR: 128mW/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). [Step 2] Blue 55 ± 6 mW/cm², Red 73 mW/cm² (Total mode =128 mW/cm²). [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). (Concluded as similar to predicate, and individual power mode densities noted not to exceed predicate.)
Total Dose for all LEDs: Similar to predicate (e.g., TheraFace: Blue = 137.4 J/cm², Red = 156.7 J/cm², Red+IR = 274.7 J/cm², Total = 568.8 J/cm²)	Skin Sustain: Total Blue dose = 137.4 J/cm², Total Red/IR = 156.7 J/cm².Skin Clearing Total: Total Blue dose = 137.4 J/cm², Total Red/IR = 431.4 J/cm².Better Aging: Total Red/IR = 431.4 J/cm².(Concluded as equivalent to total/cumulative dose provided by predicate when used to treat both facial wrinkles and mild-to-moderate inflammatory acne, considering red and IR equal.)
Wavelength: Similar to predicate/reference (e.g., Red: 630-633 ±10nm, Blue: 415 ±10nm, IR: 830-833 ±10nm)	Red: 630 ±10nm, Blue: 415 ±10nm, IR: 830 ± 10 nm. (Same)
Irradiance Source: LEDs	LEDs. (Same)
Treatment Duration: Similar to predicate (e.g., TheraFace: 3 minutes per light mode, 2-5 times/week)	Skin Sustain: 4.3 min (daily after 8 weeks). Skin Clearing: 8.4 min (daily for at least 8 weeks). Better Aging: 6.4 min (daily for at least 8 weeks). (Noted as "slightly different" but total dose is "the same as that provided by the predicate device.")
Light Distribution Uniformity: Uniform distribution of light.	Bench testing confirmed uniform distribution, with calculated median LED distance essentially equivalent to predicate, and LED beams overlapping to uniformly distribute light.
Electrical Safety: Compliance with IEC 60601-1.	Complies with IEC 60601-1:2005/AMD2:2020 and IEC 60601-1-11:2015/AMD1:2020.
Photobiological Safety: Compliance with IEC 62471 and IEC 60601-2-57 (or 60601-2-83).	Complies with IEC 62471:2006 and IEC 60601-2-83.
EMC: Compliance with IEC 60601-1-2.	Complies with IEC 60601-1-2:2014 +AMD1:2020.
Biocompatibility: Compliance with ISO 10993 series.	Complies with ISO 10993-1, -5, -10, -23. (Predicate also compliant with ISO 10993-11, which CryoGlow doesn't explicitly list as meeting, but states "Tested for Biocompatibility? Yes", implying sufficient testing).
Human Factors/Usability: Safe and effective use by intended users.	Human factors/usability study conducted in accordance with FDA guidance to demonstrate safe and effective use.

Study Details Proving Device Meets Acceptance Criteria:

Sample sizes used for the test set and the data provenance:
- The document describes non-clinical bench testing and a human factors/usability study. It does not specify a "test set" in the context of clinical accuracy data (e.g., as in an AI/imaging device).
- For the bench testing validating optical parameters (power density, total dose, wavelength, light distribution), the sample size would typically refer to the number of devices tested, but this is not explicitly stated. The provenance is internal company testing ("Bench testing was conducted...").
- For the human factors/usability study, the sample size (number of participants) is not mentioned. Data provenance would be prospective, likely in a simulated or real-world use environment.
- No clinical efficacy data (e.g., improvement in wrinkles, reduction in acne lesions on human subjects) is provided or referenced, as it is a 510(k) based on substantial equivalence, relying on the predicate device's established efficacy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. There is no mention of an expert-adjudicated ground truth for a clinical test set to evaluate efficacy, as the submission relies on substantial equivalence to a predicate device for its indications for use.
- The "experts" involved would be the engineers and scientists conducting the non-clinical bench tests and human factors specialists conducting the usability study, following recognized standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no clinical imaging or diagnostic test set requiring expert adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an LED therapy mask, not an AI-assisted diagnostic imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device; it's not a standalone algorithm in the sense of AI. Its "performance" is its ability to emit light at specific parameters and be used safely and effectively by a human.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the technical parameters, the "ground truth" is established by measurement against engineering specifications and applicable international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62471, ISO 10993 series). This is objective measurement data.
- For human factors, the "ground truth" is ensuring the device can be safely and effectively used by lay users as per the study design and FDA guidance. This involves observing user interaction and identifying potential use errors.
- For efficacy, the "ground truth" for the claims (wrinkle reduction, acne treatment) is implicitly the prior clearance of the predicate device based on its own clinical evidence. The CryoGlow device demonstrates equivalent energy delivery parameters, thus inferring equivalent efficacy.
The sample size for the training set:
- Not applicable. This device is not an AI/machine learning algorithm that requires a "training set" of data.
How the ground truth for the training set was established:
- Not applicable. As above, no AI-related training set is involved.

Summary of the Study per the Document for 510(k) Clearance:

The "study" in this context refers to a series of non-clinical tests and a Human Factors/Usability study designed to demonstrate that the CryoGlow device is substantially equivalent to existing predicate devices.

Type of Study: Non-clinical bench testing and a human factors/usability study. No clinical efficacy trials were performed.
Purpose: To demonstrate substantial equivalence to the predicate TheraFace device and reference MZ Skin LightMAX device, by showing that differences do not raise new questions of safety or effectiveness.
Key Findings:
- Optical parameters (wavelength, power/power density, total dose per mode) are either the same or engineered to deliver equivalent therapeutic effects compared to the predicate, accounting for differences in LED count and treatment times.
- Safety (electrical, photobiological, EMC, biocompatibility) is confirmed by compliance with recognized international standards (IEC 60601 series, IEC 62471, ISO 10993 series).
- Human factors study confirmed safe and effective use by intended users.
Ground Truth for Non-Clinical Tests: Objective measurements against engineering specifications and compliance with established international safety and performance standards.
Ground Truth for Human Factors: Observation and analysis of user interaction to identify and mitigate potential use errors, confirming the device can be used safely and effectively by lay users.

Summary

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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.

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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

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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

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Indications for Use

510(k) Number (if known) K242796

Device Name CryoGlow (FW3XXXX)

Indications for Use (Describe)

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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510(k) Summary K242796

Date:	November 13, 2024
Submitter:	SharkNinja Operating, LLC89 A Street, Suite 100Needham, MA 02494
Contact person:	Alyssa AquinoEmail: AAquino@sharkninja.comTel: 617-546-5768
ApplicationCorrespondent:	Lynette ZentgraftCovington & Burling, LLPEmail: lzentgraft@cov.comTel: 202-662-5404
Device TradeName:	CryoGlow LED mask (FW3XXXX)
Common Name:	Laser surgical instrument for use in general and plastic surgery and indermatology
ClassificationName:	Light Based Over the Counter Wrinkle Reduction Device
Classification:	Class II
Review Panel:	General & Plastic Surgery
RegulationNumber:	21 CFR 878.4810
Product Code:	OHS, OLP
PredicateDevice:	TheraFaceK230293Product codes OHS, OLP21 CFR 878.4810Class II
ReferenceDevice:	MZ Skin LightMAX Supercharged LED Mask 2.0K213184

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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 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 ofComparison	Proposed DeviceCryoGlow	Predicate DeviceTheraFace	Reference DeviceMZ SkinLightMAXSuperchargedLED Mask 2.0	Comment
510(k)SubmissionNumber		K230293	K213184
Trade Name	CryoGlow	TheraFace	MZ SkinLightMAXSupercharged LEDMask 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 LEDmask emits energy inthe red and infraredlight spectrum for thetreatment of fine linesand wrinkles and in thered, blue and infraredlight spectrum for thetreatment of mild-to-moderate inflammatoryacne.	Red light isintended to treatfull face wrinklesBlue light isintended to treatmild to moderateinflammatory acneRed and infraredlight is intended totreat full facewrinkles	The MZ SkinLightMAXSupercharged LEDMask 2.0 is anover-the-counterdevice intended toemit energy in thered and blue regionof the lightspectrum,specificallyindicated to treatmild to moderateacne vulgaris of theface.The MZ SkinLightMAXSupercharged LEDMask 2.0 is anover-the-counterdevice intended toemit energy in thered and Near Infra-red spectrum and isintended for the usein the treatment offull-face wrinkles.	Similar to thepredicatedevice andreferencedevice.
Prescription/OTC	OTC	OTC	OTC	Same
Power Source	2 Li-Ion Batteries 3.6V,2350 mAh total,	5-15V DC 2.5Amax powered by 2	Rechargeable Li-Ion polymer battery	Similar
Software/Firmware/MicroprocessorControl	USB-C charging cordto USB-A chargingblock	3.7V 1500mAh),charged viaUniversal USBcharger cord or fastcharger 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/cm²Total mode = 128 mW/cm²Skin Clearing [Step 1]:Blue 64 ± 8 mW/cm²,IR 64.0 ± 5 mW/cm²Total mode =128 mW/cm²Skin Clearing [Step 2]:Blue 55 ± 6 mW/cm²,Red 73 mW/cm²Total mode =128 mW/cm²Skin Clearing [Step 3]:Red 73 mW/cm², IR 55 ± 5mW/cm²,Total mode =128 mW/cm²Better Aging:Red 64 ± 5mW/cm², IR 64 ± 5 mW/cm²Total mode = 128 mW/cm²	Modes:Red: 73 ± 5mW/cm²Blue: 64 ± 5mW/cm²Red+IR: 73 ± 5mW/cm² / 55 ± 5 mW/cm² =128mW/cm²	Acne:Blue 28mW/cm²Red 16 mW/cm²Total = 44 mW/cm²Wrinkles:Red 19 mW/cm²NIR 11 mW/cm²Total = 29 mW/cm²	Similar to thepredicatedevice
Total Dose for allLEDs	Skin Sustain:	Blue = $137.4 J/cm^2$	Acne:	Similar to thepredicatedevice.
	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/cumulativedose (modes are runback-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 ± 10nm	NIR: 833 ±10nm
Irradiance Source	LEDs	LEDs	LED	Same
Total Number ofLEDS	480 (160 tri-wickpackages)	648 (216 tri-wickpackages)	unknown	Similar to thepredicatedevice (thesize of the ofLEDs are thesame)
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 weeksWrinkles: 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?	YesTested against IEC 60601-1 (see cover note to electrical, mechanical, and thermal testing section)	YesComplies with IEC 60601-1	YesComplies with IEC 60601-1	Same
Tested for Photobiological Safety?	YesComplies with IEC 62471Complies with IEC 60601-2-83	YesComplies with IEC 62471Complies with IEC 60601-2-57	YesComplies with IEC 62471	Same
Tested for EMC?	YesComplies with IEC 60601-1-2	YesComplies with IEC 60601-1-2	YesComplies with IEC 60601-1-2	Same
Tested forBiocompatibility?	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

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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

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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.

Regulation Number and Section

§ 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.