| Primary Device ID | 00854103007134 |
| NIH Device Record Key | 686322cb-f670-4277-b272-beee4e52f700 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Empower IQ Delivery System |
| Version Model Number | PRD-000758-010-00-L |
| Company DUNS | 858768943 |
| Company Name | LITECURE LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| 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 | 00854103007134 [Primary] |
| ILY | Lamp, Infrared, Therapeutic Heating |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-08 |
| Device Publish Date | 2022-06-30 |
| 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 | 2022-07-08Smart Hand Piece (SHP)_800um Fiber Assy v2 |
| 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 |