FormaI
GUDID 07290016633658
i-Forma Applicator applies RF energy through bipolar electrodes. The applicator has 2 RF electrodes, handle, cable, connector, and temperature sensors.
INMODE M.D LTD
Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator Radio-frequency skin surface treatment system applicator| Primary Device ID | 07290016633658 |
| NIH Device Record Key | 686777a6-c4ff-405f-a803-c7bcb1854c36 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FormaI |
| Version Model Number | AG609417A |
| Company DUNS | 600417351 |
| Company Name | INMODE M.D LTD |
| 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 |
Operating and Storage Conditions
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 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 |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 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 |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 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 |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 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 |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 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 |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 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 |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 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 |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 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 |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 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 |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 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 |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 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 |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 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 |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 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 |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 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 |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 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 |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 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 |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 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 |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290016633658 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K210492
FDA Product Code
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-11-03 |
| Device Publish Date | 2022-01-05 |
Devices Manufactured by INMODE M.D LTD
| 07290019863045 - InMode RF hand piece | 2024-05-03 Handpiece comprises internal active electrode, external return electrode, both with temperature sensor, handle, cable and connec |
| 07290019863052 - InMode RF hand piece | 2024-05-03 Handpiece comprises internal active electrode, external return electrode, both with temperature sensor, handle, cable and connec |
| 07290016633726 - Envision System | 2024-04-01 The Envision Platform with Forma-I, Forma, Morpheus8 and Lumecca Applicators employs two different technologies for various aest |
| 07290019863021 - Morpheus8C Handpiece | 2024-04-01 Morpheus8C Handpiece is intended for use in dermatologic procedures for electrocoagulation and hemostasis. |
| 07290019863250 - Ignite RF System | 2024-04-01 The Ignite RF System employs radiofrequency (RF) energy for use in dermatological and general surgical procedures for electrocoa |
| 07290019863311 - InMode OP | 2024-04-01 The InMode OP System is employing three different technologies for various aesthetic applications – Laser, Intense Pulsed Ligh |
| 07290019863014 - CelluTite System | 2024-03-27 The CelluTite System with the BodyFX and Plus Handpieces is a medical aesthetic device combining mechanical vacuum skin massagin |
| 07290019863236 - OptimasMax platform | 2024-03-27 The OptimasMax system is employing three different technologies for various aesthetic applications – Laser, Intense Pulsed Lig |
Trademark Results [FormaI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FORMAI 98220435 not registered Live/Pending |
IZEA Worldwide, Inc. 2023-10-12 |
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