FDA.reportPublic FDA data

Empower Delivery System

Primary DI
00854103007196
Brand
Empower Delivery System
Company
LITECURE LLC
Model
PRD-000477-000-04-L
Device description
Legacy Hand Piece 600um Fiber Hand Piece w/ Finger Switch, Dark Gray
Published
2022-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854103007196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854103007196008541030071968541030071960854103007196

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal/physical therapy laser beam guide, transcutaneousA noninvasive, hand-held device intended to be connected to a laser unit intended for musculoskeletal therapy [e.g., infrared phototherapy laser, low-level laser therapy (LLLT) system] to deliver visible red/infrared laser light energy to the skin-surface for localized treatment of underlying musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It is a handpiece-like device with fibreoptic materials and may include a manual massager as an adjunct to laser energy therapy. It is intended to be operated by a healthcare professional exclusively in a clinical setting. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
858768943
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854103007004LightForce PROLTC-9002017-02-07
00854103007011LightForce FXLTC-15002017-02-07
00854103007028LightForce EXLTS-15002017-02-07
00854103007035LightForce EXPLTS-1500P2017-02-07
00854103007295LightForce XLTC-1001-L-B62022-11-03
00854103007097LightForce FXiLTC-1510-L-B62020-10-30
00854103007103LightForce XPiLTS-2500-L-S82020-10-30
00854103007073LightForce XLiLTS-4000-L2019-12-13
00854103007066SoLa Therapy LaserLTC-1510-SOLA2019-06-20
00854103007042LightForce FXiLTC-15002017-07-24
00854103007059LightForce EXPiLTS-25002017-07-24
00854103007332Large Massage BallPRD-000229-010-002022-11-22
00854103007349Flat WindowPRD-000233-0002022-11-22
00854103007318XL ConePRD-000644-0002022-08-23
00854103007325XL Rolling PinPRD-000721-0002022-08-23
00854103007110Empower Delivery SystemPRD-000424-010-01-L2022-06-30
00854103007134Empower IQ Delivery SystemPRD-000758-010-00-L2022-06-30
00854103007165Empower Delivery SystemPRD-000477-000-01-L2022-06-30
00854103007172Empower Delivery SystemPRD-000477-000-02-L2022-06-30
00854103007189Empower Delivery SystemPRD-000477-000-03-L2022-06-30

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Primary DI, Brand, Company table
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B347BDRCK0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
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B108043POEMVMUS00EMVITALBTL INDUSTRIES LIMITEDILY2025-11-19
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