Empower Delivery System

GUDID 00854103007189

Legacy Hand Piece 600um Fiber Hand Piece w/ Finger Switch, Cool Gray

LITECURE LLC

Musculoskeletal/physical therapy laser beam guide, transcutaneous
Primary Device ID00854103007189
NIH Device Record Keyda707640-2aca-4238-a094-ef0a252834db
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmpower Delivery System
Version Model NumberPRD-000477-000-03-L
Company DUNS858768943
Company NameLITECURE LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100854103007189 [Primary]

FDA Product Code

ILYLamp, Infrared, Therapeutic Heating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-08
Device Publish Date2022-06-30

On-Brand Devices [Empower Delivery System]

00854103007196Legacy Hand Piece 600um Fiber Hand Piece w/ Finger Switch, Dark Gray
00854103007189Legacy Hand Piece 600um Fiber Hand Piece w/ Finger Switch, Cool Gray
00854103007172Legacy Hand Piece 800um Fiber Hand Piece w/ Finger Switch, Dark Gray
00854103007165Legacy Hand Piece 800um Fiber Hand Piece w/ Finger Switch, Cool Gray
00854103007110Basic Hand Piece (BHP)_600um Fiber Assy (White)

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