Scanning System for LS-6000

GUDID B108451POSCAEL2MUS00

BTL INDUSTRIES LIMITED

Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner
Primary Device IDB108451POSCAEL2MUS00
NIH Device Record Key3c7bff3c-9921-4ff1-b4ea-3b7be0b7c1a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameScanning System for LS-6000
Version Model NumberScanning System for LS-6000
Company DUNS733532951
Company NameBTL INDUSTRIES LIMITED
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
HIBCCB108451POSCAEL2MUS00 [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 Date2024-04-01
Device Publish Date2024-03-22

Devices Manufactured by BTL INDUSTRIES LIMITED

B108043PO30WMUS00 - LS-60002024-04-01
B108451POSCAEL2MUS00 - Scanning System for LS-60002024-04-01
B108451POSCAEL2MUS00 - Scanning System for LS-60002024-04-01
B108899AP2C2MUS20 - Small applicator2023-12-18
B108899AP2C45MUS10 - Edge applicator2023-12-18
B108899APC1ENUS0140 - Large applicator2023-12-18
B108899PO11C1ENUS0140 - EMSCULPT NEO2023-12-18
B108785PO8MUS00 - BTL-785F2023-12-11
B108785PO9MUS00 - BTL-785F2023-12-11
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