DEVICE: ACDUAL applicator (07290016540451)

Device Identifier (DI) Information

ACDUAL applicator
AS120058
In Commercial Distribution

VENUS CONCEPT LTD
07290016540451
GS1

1
533127663 *Terms of Use
IPL applicator intended to be used for the treatment of acne vulgaris.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K153717 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

658603b1-2c2b-4008-b374-4563ec22a1c1
July 06, 2018
3
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
07290016540567 1 07290016540451 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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