BTL INDUSTRIES LIMITED

BTL INDUSTRIES LIMITED

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Electrosurgical, Cutting & Coagulation & Accessories (GEI) (5) Powered Light Based Non-Laser Surgical Instrument With Thermal Effect (ONF) (3) Massager, Vacuum, Radio Frequency Induced Heat (PBX) (2)

Premarket Exempt

No Yes

Clear

Exilis large applicator - B108215APLAT0 Catalog Number :

Device Class : 2

Duns Number: 733532951

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Exilis large applicator - B108215APLATENUS0 Catalog Number :

Device Class : 2

Duns Number: 733532951

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

XP 2 applicator - B108215APSAPWRE1000 Catalog Number :

Device Class : 2

Duns Number: 733532951

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

XP applicator - B108215APSAPWRT0 Catalog Number :

Device Class : 2

Duns Number: 733532951

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

XP applicator - B108215APSAPWRTENUS0 Catalog Number :

Device Class : 2

Duns Number: 733532951

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Exilis small applicator - B108215APSAUSNPTENUS0 Catalog Number :

Device Class : 2

Duns Number: 733532951

Premarket Exempt : No

Product Code : PBX

Prescription Use : Yes

Device Count : 1

BTL Exilite handpiece - B108216APIPLF1140ENUS0 Catalog Number :

Device Class : 2

Duns Number: 733532951

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

BTL Exilite handpiece - B108216APIPLF1140US0 Catalog Number :

Device Class : 2

Duns Number: 733532951

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

BTL Exilite handpiece - B108216APIPLF1140US1020 Catalog Number :

Device Class : 2

Duns Number: 733532951

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

EMTONE applicator - B108284AP01EMTENUS0100 Catalog Number :

Device Class : 2

Duns Number: 733532951

Premarket Exempt : No

Product Code : PBX

Prescription Use : Yes

Device Count : 1

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