| Primary Device ID | 07290016633108 |
| NIH Device Record Key | 5a74dc38-f282-4a50-9a36-37a9e61794d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lumecca 515 |
| Version Model Number | AS601863A |
| Catalog Number | AS601863A |
| Company DUNS | 600417351 |
| Company Name | INMODE M.D LTD |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
| Phone | 1-887-367-4556 |
| contact@inmode.com |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 90 KiloPascal and 110 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290016633108 [Primary] |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-01-07 |
| Device Publish Date | 2016-10-25 |
| 07290019863267 - Luxora System | 2025-08-19 The Luxora™ device is based on the InMode RF Pro™ platform. The Luxora system employs radiofrequency (RF) energy for use in |
| 07290016633313 - Plus Applicator | 2025-08-04 Plus (Plus Plus) |
| 07290019863359 - ApexRF Applicator | 2025-06-12 ApexRF handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and te |
| 07290019863274 - InMode RF hand piece | 2025-02-28 AccuTite HP 2 Pack black |
| 07290019863281 - InMode RF hand piece | 2025-02-28 FaceTite 2-Pack black |
| 07290019863298 - InMode RF hand piece | 2025-02-28 InModeRF HP 17x22x46 black |
| 07290019863342 - APEX RF System | 2025-01-17 Apex RF system employs radiofrequency (RF) energy for use in dermatological procedures. |
| 07290016633573 - Define System | 2025-01-15 The DEFINE System is designed to deliver non-thermal RF energy to the skin and subdermal fat. . |