DEVICE: SensiLight Mini - mint (05060445340043)
Device Identifier (DI) Information
SensiLight Mini - mint
IPL030US01SNS
In Commercial Distribution
EL GLOBAL TRADE LTD
IPL030US01SNS
In Commercial Distribution
EL GLOBAL TRADE LTD
The sensiLight Mini is an over the counter device intended for the removal of unwanted hair.
The sensiLight Mini is also intended for permanent reduction in hair regrowth, defined as a long-term,
stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the
completion of treatment regimen.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
58935 | Intense pulsed light skin surface treatment system |
A mains electricity (AC-powered) mobile (on wheels) device designed to produce strong, controlled flashes of filtered light in the wavelength range 400 - 1200nm [intense pulsed light (IPL)] for heat ablation of pigmented skin cells (selective photothermolysis) to treat multiple skin/pigmentation conditions. The device typically enables variation of treatment parameters (wavelength, duration of impulses, single/multiple impulses) for treatment of conditions such as acne, telangiectasia, pigmentation (freckles, sun spots, liver spots) and/or for hair reduction. It consists of a control unit with user interface display and control panel, and a wire-connected applicator.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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OHT | Light Based Over-The-Counter Hair Removal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3a015ca6-0248-4e44-b125-3b21ef618ae1
October 19, 2021
4
October 19, 2016
October 19, 2021
4
October 19, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
855-736-7422
support@sensica.com
support@sensica.com