Primary Device ID | 00854103007059 |
NIH Device Record Key | afc8d452-ab5e-42b2-8b32-ccbffe253c20 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | LightForce EXPi |
Version Model Number | LTS-2500 |
Company DUNS | 858768943 |
Company Name | LITECURE LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00854103007059 [Primary] |
PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 7 |
Public Version Date | 2020-03-31 |
Device Publish Date | 2017-07-24 |
00854103007332 - Large Massage Ball | 2022-11-30 BDA Attachment head Large Ball |
00854103007349 - Flat Window | 2022-11-30 BDA Attachment head Flat Window |
00854103007295 - LightForce X | 2022-11-11 Infrared phototherapy device emitting up to 10 W at 810/980 nm, 7" display |
00854103007318 - XL Cone | 2022-08-31 BDA Attachment XL Cone |
00854103007325 - XL Rolling Pin | 2022-08-31 BDA Xl Rolling Pin Attachment |
00854103007110 - Empower Delivery System | 2022-07-08 Basic Hand Piece (BHP)_600um Fiber Assy (White) |
00854103007134 - Empower IQ Delivery System | 2022-07-08 Smart Hand Piece (SHP)_800um Fiber Assy v2 |
00854103007165 - Empower Delivery System | 2022-07-08 Legacy Hand Piece 800um Fiber Hand Piece w/ Finger Switch, Cool Gray |