FDA.reportPublic FDA data

LIGHTWAVE

Primary DI
G866ELITELT0
Brand
LIGHTWAVE
Company
MedAesthetics International LLC
Model
EliteLT
Catalog number
Elite_LT
Device description
The LIGHTWAVE Elite is a professional LED light therapy system designed to provide uniform light exposure for skin treatment and therapeutic heating applications. The device utilizes visible blue, visible red, and near-infrared LED wavelengths, individually or in combination. The system consists of a main control unit with user interface controls, integrated power supply, and an LED treatment panel housed within a metal enclosure mounted on an articulating support arm. The software-controlled interface allows the operator to select and control device functions and treatment parameters.
Published
2026-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082586000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082586000LIGHTWAVE PROFESSIONAL DELUXELightwave Technologies, LLC2010-01-04GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G866ELITELT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blue/red/infrared phototherapy lampA portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
866-999-6954info@lightwavetherapy.com

Regulatory Flags#

DUNS number
144992030
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G866REACTLT0LIGHTWAVEReactLTReact_LT2026-06-08
G866REACTPRO0LIGHTWAVEReactPROReact_PRO2026-06-08

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Primary DI, Brand, Company table
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06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
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