LITECURE LLC

Address:101 Lukens Drive,New Castle,DE,19720,US

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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

Lamp, Infrared, Therapeutic Heating (ILY) (10)

Premarket Exempt

No Yes

Clear

Empower Delivery System - 00854103007110 Catalog Number :

Device Description : Basic Hand Piece (BHP)_600um Fiber Assy (White)

Device Class : 2

Duns Number: 858768943

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : Yes

Device Count : 1

Empower IQ Delivery System - 00854103007134 Catalog Number :

Device Description : Smart Hand Piece (SHP)_800um Fiber Assy v2

Device Class : 2

Duns Number: 858768943

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : Yes

Device Count : 1

Empower Delivery System - 00854103007165 Catalog Number :

Device Description : Legacy Hand Piece 800um Fiber Hand Piece w/ Finger Switch, Cool Gray

Device Class : 2

Duns Number: 858768943

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : Yes

Device Count : 1

Empower Delivery System - 00854103007172 Catalog Number :

Device Description : Legacy Hand Piece 800um Fiber Hand Piece w/ Finger Switch, Dark Gray

Device Class : 2

Duns Number: 858768943

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : Yes

Device Count : 1

Empower Delivery System - 00854103007189 Catalog Number :

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

Device Class : 2

Duns Number: 858768943

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : Yes

Device Count : 1

Empower Delivery System - 00854103007196 Catalog Number :

Device Description : Legacy Hand Piece 600um Fiber Hand Piece w/ Finger Switch, Dark Gray

Device Class : 2

Duns Number: 858768943

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : Yes

Device Count : 1

Large Massage Ball - 00854103007202 Catalog Number :

Device Description : BDA Attachment head Large Ball

Device Class : 2

Duns Number: 858768943

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : Yes

Device Count : 1

Large Cone - 00854103007219 Catalog Number :

Device Description : BDA Attachment Head Large Cone

Device Class : 2

Duns Number: 858768943

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : Yes

Device Count : 1

Small Massage Ball - 00854103007226 Catalog Number :

Device Description : BDA Attachment head Small Ball

Device Class : 2

Duns Number: 858768943

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : Yes

Device Count : 1

Flat Window - 00854103007233 Catalog Number :

Device Description : BDA Attachment head Flat Window

Device Class : 2

Duns Number: 858768943

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : Yes

Device Count : 1

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