FDA.reportPublic FDA data

N/A

Primary DI
08809447652122
Brand
N/A
Company
Lutronic Corporation
Model
Goggle ASSY (For patient)
Device description
Goggle ASSY (For patient) of HEALITE II / Rubber goggle
Published
2018-08-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

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
K113668000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113668000HEALITE II SYSTEMLutronic Corporation2012-06-19ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809447652122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809447652122088094476521228809447652122

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
215-205-2219jvojir@lutronic.com

Regulatory Flags#

DUNS number
688282516
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809447650883INFINIINFINI MFR G U110V2016-09-09
08809447650982N/AMFR Handpiece 2016-09-09
08809447651019N/AHandpiece cradle2016-09-09
08809447651675N/A830&590nm Head2016-09-09
08809447651699Healite IIHealite Body Assy2016-09-09
08809447651729N/AArm2016-09-09
08809447651781N/ATIP A-49 1 ea2016-11-18
08809447652375INFINI49 pin Tip (Standard) 1 ea2019-01-15
08809447652399INFINI16 pin Tip (Optional) 1 ea2019-01-15
08809447651033N/AMFR 49 TIP II 1 ea2016-09-09
08809447651064N/ATIP A-16 1 ea2016-09-09
08809447651170N/AINFINI Operator's Manual USA2016-09-09
08809447651712N/AManual2016-09-09
08809447652139N/APatient Goggle2018-08-06
08809447652351INFINI49 pin (Enhanced) 1 ea2019-01-15
08809447657424MOSAIC 3DPill Tip Package2025-11-28
08809447657745XERFXERF EFFECTOR 60(600)2025-11-28
08809447657011MOSAIC 3DMOSAIC 3D2025-11-28
08809447657370MOSAIC 3DSapphire Tip Package2025-11-28
08809447657387MOSAIC 3DRoller Tip Package2025-11-28

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