OrthoPulse

Primary DI
09120118090029
Brand
OrthoPulse
Company
Biolux Technology GmbH
Model
OPi
Catalog number
OPi-NA100
Published
2021-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PLHOrthodontic Led Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLHOrthodontic Led AccessoryDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143120000OrthoPulseBiolux Research , Ltd.2015-07-24PLH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815950000013PreviousGS10
09120118090029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815950000013008159500000138159500000130815950000013
09120118090029091201180900299120118090029

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
8886690674support@orthopulse.com

Regulatory Flags#

DUNS number
300613819
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
91201180900032OrthoPulseOrthoPulse Lite2026-03-11
09120118090074OrthoPulseOrthoPulse 2.0 ExtendedOPi2E-1002023-08-29
09120118090067OrthoPulseOrthoPulse 2.0 StandardOPi2S-1002022-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
91201180900032OrthoPulseBiolux Technology GmbHPLH2026-03-11
09120118090074OrthoPulseBiolux Technology GmbHPLH2023-08-29
09120118090067OrthoPulseBiolux Technology GmbHPLH2022-07-16
00815950000013OrthoPulseBiolux Research LimitedPLH2016-08-23