DEVICE: Lumecca 580 (07290016633115)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Multi-modality skin surface treatment system | A mains electricity (AC-powered) mobile (on wheels) assembly of devices that uses multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, and radio-frequency (RF) energy] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes a lamp(s) and additional energy sources (typically a laser(s), and/or a RF generator); dedicated applicators (handpieces) intended to apply the different energies to the skin are also included. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K123860 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -20 and 65 Degrees Celsius |
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 50 and 110 KiloPascal |
Handling Environment Temperature: between 15 and 30 Degrees Celsius |
Handling Environment Humidity: between 30 and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 90 and 110 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b6aa2323-2611-4428-b20b-b140a89e5d71
January 07, 2019
3
October 25, 2016
January 07, 2019
3
October 25, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-887-367-4556
contact@inmode.com
contact@inmode.com