Organization name

SharkNinja Operating LLC

SRN

US-MF-000048207

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• Ask your pharmacist or doctor for advice before using or taking the product (e.g. if pregnant or breastfeeding)

  Do not use the Shark CryoGlow Mask if you are taking: ​ Medication or supplements that cause sensitivity to light (photosensitivity), for example, medications for severe inflammatory acne (i.e. isotretinoin or doxycycline).​ Immediately stop using the device if you experience any discomfort. ​ Do not use the Shark CryoGlow Mask if you have any of the following medical conditions: ​ Retinal and/or macular disease, ocular albinism, or any eye condition that causes sensitivity to light Pregnant, nursing, or maybe pregnant Pacemaker or other electronic implanted device Implants in the face Lack of sensation (e.g., numbness) Light sensitive skin disorder (e.g., lupus, porphyria) Extreme light sensitivity of the eyes (i.e., photophobia) Light-induced headaches Albinism Melasma (i.e., condition that causes patches and spots) Sensitivity or allergy to plastic, aluminum, or self-fastening material

• Caution

  Do not use the Shark CryoGlow Mask if you have any of the following conditions on the face, hairline, ears, or neck: ​ Recent facial surgery (until you have been cleared by your doctor) ​ Suspicious lesions or skin cancer Eczema Psoriasis Irregularly shaped, new, or changing brown spots Birthmarks Broken skin, skin rash, or blisters Tissue inflammation Skin infection, cold sore, or warts Active current outbreak of herpes simplex virus (cold sores)​ History of herpes outbreaks without receiving preventative treatment​ Facial treatment where the skin has not fully healed, including neurotoxin, dermal filler, micro needling, laser, or chemical peel Do not apply the Shark CryoGlow Mask’s cooling treatments on the eyeball or upper eyelid. ​ Do not use the Shark CryoGlow Mask’s cooling treatments if you have any of the following medical conditions: Cold hypersensitivity​ Cold urticaria (i.e., hives brought on by cold temperatures) Circulatory insufficiency PRECAUTIONS: Consult a medical professional before using the Shark CryoGlow Mask if: ​ You have bruising on the face. ​ You are experiencing skin sensitivity or irritation with retinol or benzoyl peroxide.​

Primary placement in Ireland; available across 17 countries total.

Trade name

Shark CryoGlow

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

06223564363662

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

0622356FW300JA

Reference / catalog number

FW313EUPU

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Shark CryoGlow LED Facemask

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12040202PHOTOTHERAPY EQUIPMENT

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.