OrthoPulse

Primary DI
09120118090067
Brand
OrthoPulse
Company
Biolux Technology GmbH
Model
OrthoPulse 2.0 Standard
Catalog number
OPi2S-100
Published
2022-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
09120118090067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120118090067091201180900679120118090067

GMDN Terms#

Term, Definition table
TermDefinition
Red-light phototherapy unitAn electrically-powered device designed to emit red light for phototherapy primarily to accelerate healing of cutaneous/mucosal wounds, treat mild skin disorders (e.g., mild acne), intraoral or nasal conditions, and/or treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood flow. It may have various designs (e.g., hand-held, arched bar, flexible pad for adapting to body areas) and is intended for use in the home and clinical settings.

Sterilization Methods#

Method table
Method

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
09120118090029OrthoPulseOPiOPi-NA1002021-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
91201180900032OrthoPulseBiolux Technology GmbHPLH2026-03-11
09120118090074OrthoPulseBiolux Technology GmbHPLH2023-08-29
09120118090029OrthoPulseBiolux Technology GmbHPLH2021-06-30
00815950000013OrthoPulseBiolux Research LimitedPLH2016-08-23