FDA.reportPublic FDA data

Applied BioPhotonics Phototherapy System

Primary DI
04719873240029
Brand
Applied BioPhotonics Phototherapy System
Company
APPLIED BIOPHOTONICS LIMITED
Model
ABPT1003-2
Device description
a cosmetic outlook improved version if compare with the previous ABPT1003 device. so, this is a Mark II version with slight change to the machine outlook.
Published
2021-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142256000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142256000Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics , Ltd.2015-01-07ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719873240029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719873240029047198732400294719873240029

GMDN Terms#

Term, Definition table
TermDefinition
Red-light phototherapy unit, line-poweredA mains electricity (AC-powered) device designed to emit a low-level narrow-band (LLNB) red light in the visible and invisible wavelength around 600-940 nm, with the intent to modify cellular metabolism and/or improve blood flow through increased vasodilation primarily for the accelerated healing of cutaneous or mucosal wounds and/or to provide pain relief. It can be used in a healthcare facility and in the home. It may be used to help treat skin ulcers, acne, herpes simplex lesions, and postoperative wounds, or to relieve pain associated with inflammatory processes such as rheumatoid arthritis (RA) or lower back injury.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9999999999support@AppliedBioPhotonics.com
+88636218538support@AppliedBioPhotonics.com

Regulatory Flags#

DUNS number
686942324
Device count
1
Combination product
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719873240012Applied BioPhotonics Phototherapy SystemABPT10032016-09-23

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Primary DI, Brand, Company table
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