CryoGlow (FW3XXXX)

K242796 · Sharkninja Operating, LLC · OHS · Nov 27, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K242796
• Device Name: CryoGlow (FW3XXXX)
• Applicant: Sharkninja Operating, LLC
• Product Code: OHS · General, Plastic Surgery
• Decision Date: Nov 27, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

CryoGlow is an OTC wearable LED mask for facial skin treatment. Device uses 480 LEDs to emit red, blue, and infrared light in three user-selectable routines: Better Aging, Skin Clearing, and Skin Sustain. Includes under-eye cooling via Peltiers and fans to refresh/soothe skin. Operated by user via remote controller and GUI. Safety features include silicone eye shields, auto-shutoff, and auto-dimming when removed from face. Powered by rechargeable Li-Ion batteries. Output is light energy delivered to skin; cooling function provides thermal sensation. Benefits include reduction of wrinkles and acne. Used in home environment by consumer.

Clinical Evidence

Bench testing only. No clinical trials performed. Testing included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), photobiological safety (IEC 62471), and biocompatibility (ISO 10993 series). Bench studies verified peak wavelengths, power density, and total energy dose equivalence to predicate. Human factors/usability study conducted to confirm safe/effective use in intended environment.

Technological Characteristics

Molded plastic (ABS + MABS) mask with 480 LEDs (160 tri-wick packages). Wavelengths: Red (630±10nm), Blue (415±10nm), IR (830±10nm). Energy source: 2 Li-Ion batteries (3.6V, 2350 mAh). Connectivity: USB-C charging. Cooling: Peltier-based chill pads. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62471, ISO 10993-1/5/10/23.

Indications for Use

Indicated for treatment of fine lines and wrinkles (red/infrared light) and mild-to-moderate inflammatory acne (red/blue/infrared light) in adult patients.

Regulatory Classification

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.

Predicate Devices

• TheraFace (K230293)

Reference Devices

• MZ Skin LightMAX Supercharged LED Mask 2.0 (K213184)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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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# 510(k) Summary K242796

| Date: | November 13, 2024 |
|-------------------------------|-------------------------------------------------------------------------------------------------|
| Submitter: | SharkNinja Operating, LLC<br>89 A Street, Suite 100<br>Needham, MA 02494 |
| Contact person: | Alyssa Aquino<br>Email: [e-mail]<br>Tel: [phone] |
| Application<br>Correspondent: | Lynette Zentgraft<br>Covington & Burling, LLP<br>Email: [e-mail]<br>Tel: [phone] |
| Device Trade<br>Name: | CryoGlow LED mask (FW3XXXX) |
| Common Name: | Laser surgical instrument for use in general and plastic surgery and in<br>dermatology |
| Classification<br>Name: | Light Based Over the Counter Wrinkle Reduction Device |
| Classification: | Class II |
| Review Panel: | General & Plastic Surgery |
| Regulation<br>Number: | 21 CFR 878.4810 |
| Product Code: | OHS, OLP |
| Predicate<br>Device: | TheraFace<br>K230293<br>Product codes OHS, OLP<br>21 CFR 878.4810<br>Class II |
| Reference<br>Device: | MZ Skin LightMAX Supercharged LED Mask 2.0<br>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<br>Comparison | Proposed Device<br>CryoGlow | Predicate Device<br>TheraFace | Reference Device<br>MZ Skin<br>LightMAX<br>Supercharged<br>LED Mask 2.0 | Comment |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| 510(k)Submission<br>Number | | K230293 | K213184 | |
| Trade Name | CryoGlow | TheraFace | MZ Skin<br>LightMAX<br>Supercharged LED<br>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<br>mask emits energy in<br>the red and infrared<br>light spectrum for the<br>treatment of fine lines<br>and wrinkles and in the<br>red, blue and infrared<br>light spectrum for the<br>treatment of mild-to-<br>moderate inflammatory<br>acne. | Red light is<br>intended to treat<br>full face wrinkles<br><br>Blue light is<br>intended to treat<br>mild to moderate<br>inflammatory acne<br><br>Red and infrared<br>light is intended to<br>treat full face<br>wrinkles | The MZ Skin<br>LightMAX<br>Supercharged LED<br>Mask 2.0 is an<br>over-the-counter<br>device intended to<br>emit energy in the<br>red and blue region<br>of the light<br>spectrum,<br>specifically<br>indicated to treat<br>mild to moderate<br>acne vulgaris of the<br>face.<br><br>The MZ Skin<br>LightMAX<br>Supercharged LED<br>Mask 2.0 is an<br>over-the-counter<br>device intended to<br>emit energy in the<br>red and Near Infra-<br>red spectrum and is<br>intended for the use<br>in the treatment of<br>full-face wrinkles. | Similar to the<br>predicate<br>device and<br>reference<br>device. |
| Prescription/OTC | OTC | OTC | OTC | Same |
| Power Source | 2 Li-Ion Batteries 3.6V,<br>2350 mAh total, | 5-15V DC 2.5A<br>max powered by 2 | Rechargeable Li-<br>Ion polymer battery | Similar |
| Software/Firmware/Microprocessor<br>Control | USB-C charging cord<br>to USB-A charging<br>block | 3.7V 1500mAh),<br>charged via<br>Universal USB<br>charger cord or fast<br>charger adaptor | | |
| | Yes | Yes | Yes | Same |
| Power (mW/cm²) | Skin Sustain:<br>Blue 59.8 ± 7 mW/cm²,<br>Red 17.0 ± 5mW/cm²,<br>IR 51.2 ± 5 mW/cm²<br>Total mode = 128 mW/cm²<br><br>Skin Clearing [Step 1]:<br>Blue 64 ± 8 mW/cm²,<br>IR 64.0 ± 5 mW/cm²<br>Total mode =128 mW/cm²<br><br>Skin Clearing [Step 2]:<br>Blue 55 ± 6 mW/cm²,<br>Red 73 mW/cm²<br>Total mode =128 mW/cm²<br><br>Skin Clearing [Step 3]:<br>Red 73 mW/cm², IR 55 ± 5mW/cm²,<br>Total mode =128 mW/cm²<br><br>Better Aging:<br>Red 64 ± 5mW/cm², IR 64 ± 5 mW/cm²<br>Total mode = 128 mW/cm² | Modes:<br>Red: 73 ± 5mW/cm²<br>Blue: 64 ± 5mW/cm²<br>Red+IR: 73 ± 5mW/cm² / 55 ± 5 mW/cm² =<br>128mW/cm² | Acne:<br>Blue 28mW/cm²<br>Red 16 mW/cm²<br>Total = 44 mW/cm²<br><br>Wrinkles:<br>Red 19 mW/cm²<br>NIR 11 mW/cm²<br>Total = 29 mW/cm² | Similar to the<br>predicate<br>device |
| Total Dose for all<br>LEDs | Skin Sustain: | Blue = $137.4 J/cm^2$ | Acne: | Similar to the<br>predicate<br>device. |
| | Total Blue dose =<br>$137.4 J/cm^2$ | 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<br>dose (modes are run<br>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<br>±10nm/830 ± 10<br>nm | NIR: 833 ±10nm | |
| Irradiance Source | LEDs | LEDs | LED | Same |
| Total Number of<br>LEDS | 480 (160 tri-wick<br>packages) | 648 (216 tri-wick<br>packages) | unknown | Similar to the<br>predicate<br>device (the<br>size of the of<br>LEDs are the<br>same) |
| Treatment Duration | | | | |
| | Skin Sustain: 4.3 min<br>(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)<br>Acne: 4 x weeks, 6 weeks<br>Wrinkles: 5 x weeks, 6 weeks | Similar to both the predicate and reference devices. |
| | Skin Clearing: 8.4 min<br>(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.<br>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<br>(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<br>Tested against IEC 60601-1 (see cover note to electrical, mechanical, and thermal testing section) | Yes<br>Complies with IEC 60601-1 | Yes<br>Complies with IEC 60601-1 | Same |
| Tested for Photobiological Safety? | Yes<br>Complies with IEC 62471<br>Complies with IEC 60601-2-83 | Yes<br>Complies with IEC 62471<br>Complies with IEC 60601-2-57 | Yes<br>Complies with IEC 62471 | Same |
| Tested for EMC? | Yes<br>Complies with IEC 60601-1-2 | Yes<br>Complies with IEC 60601-1-2 | Yes<br>Complies with IEC 60601-1-2 | Same |
| Tested for<br>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…