OrthoPulse

Primary DI
09120118090074
Brand
OrthoPulse
Company
Biolux Technology GmbH
Model
OrthoPulse 2.0 Extended
Catalog number
OPi2E-100
Published
2023-08-29
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
K230905000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230905000OrthoPulse 2.0E (OPi2E-100)Biolux Technology GmbH2023-06-09PLH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120118090074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120118090074091201180900749120118090074

GMDN Terms#

Term, Definition table
TermDefinition
Red-light phototherapy unit, professionalAn 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 circulation. It is a non-wearable device which may be in the form of a hand-held, freestanding or mounted unit, and is intended to be used by a healthcare professional in a clinical setting.

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
09120118090067OrthoPulseOrthoPulse 2.0 StandardOPi2S-1002022-07-16
09120118090029OrthoPulseOPiOPi-NA1002021-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
91201180900032OrthoPulseBiolux Technology GmbHPLH2026-03-11
09120118090067OrthoPulseBiolux Technology GmbHPLH2022-07-16
09120118090029OrthoPulseBiolux Technology GmbHPLH2021-06-30
00815950000013OrthoPulseBiolux Research LimitedPLH2016-08-23