DEVICE: HR650 applicator (07290016540413)
Device Identifier (DI) Information
HR650 applicator
AS120031
In Commercial Distribution
VENUS CONCEPT LTD
AS120031
In Commercial Distribution
VENUS CONCEPT LTD
IPL applicator indicated for the removal of unwanted hair and to effect stable long-term or
permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the long-term stable reduction in the
number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
45222 | Light-energy skin surface treatment system applicator |
A handpiece that is part of a skin surface treatment system that conducts one or more generated light energies [e.g., fluorescent, ultraviolet B (UVB)] used for ablative and non-ablative treatment of skin conditions (e.g., acne, psoriasis, vascular lesions, wrinkles, large pores). This device is connected to a generator and is applied by the practitioner or staff directly to the area to be treated. This is a reusable device.
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Active | false |
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 [?] |
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K153717 | 000 |
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
268a323f-808a-4e15-b8ff-2488ea584880
July 06, 2018
3
September 24, 2016
July 06, 2018
3
September 24, 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 |
---|---|---|---|---|---|
07290016540529 | 1 | 07290016540413 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined