FDA.reportPublic FDA data

Camar

Primary DI
00855264008695
Brand
Camar
Company
Aura Medical
Model
FC40
Device description
Glide Microcurrent and Light Therapy Device
Published
2026-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes
OHSLight Based Over The Counter Wrinkle Reduction
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFOStimulator, Transcutaneous Electrical, Aesthetic PurposesNeurology2
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2
OLPOver-The-Counter Powered Light Based Laser For AcneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252187000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252187000Aura Glide (FC40)Aura Medical, LLC2025-12-23NFO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855264008695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855264008695008552640086958552640086950855264008695

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Contacts#

Phone, Email table
PhoneEmail
5162531063support@camar.com

Regulatory Flags#

DUNS number
052076745
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085526400862Caring Mill by Aura SereneSR402024-11-14
00863943000120Aura MedicalNB402017-08-15

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04897111807354Project E BeautyDUPLEX INTERNATIONAL TRADING LIMITEDOLP2026-10-01
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00622356746526Shark™ CryoGlow Plus™SharkNinja Operating LLCOLP2026-08-01
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