SoLa Therapy Laser

GUDID 00854103007066

Infrared phototherapy device emitting up to 8W at 810/980nm, battery option, 10" display

LITECURE LLC

Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional
Primary Device ID00854103007066
NIH Device Record Keyf2d0d6e0-0330-4961-8d41-08e31a8bb2ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoLa Therapy Laser
Version Model NumberLTC-1510-SOLA
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 Datetrue
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
GS100854103007066 [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 Date2019-06-28
Device Publish Date2019-06-20

Devices Manufactured by LITECURE LLC

00854103007332 - Large Massage Ball2022-11-30 BDA Attachment head Large Ball
00854103007349 - Flat Window2022-11-30 BDA Attachment head Flat Window
00854103007295 - LightForce X2022-11-11 Infrared phototherapy device emitting up to 10 W at 810/980 nm, 7" display
00854103007318 - XL Cone2022-08-31 BDA Attachment XL Cone
00854103007325 - XL Rolling Pin2022-08-31 BDA Xl Rolling Pin Attachment
00854103007110 - Empower Delivery System2022-07-08 Basic Hand Piece (BHP)_600um Fiber Assy (White)
00854103007134 - Empower IQ Delivery System2022-07-08 Smart Hand Piece (SHP)_800um Fiber Assy v2
00854103007165 - Empower Delivery System2022-07-08 Legacy Hand Piece 800um Fiber Hand Piece w/ Finger Switch, Cool Gray

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