DEVICE: Neutrogena (00070501101247)

Device Identifier (DI) Information

Neutrogena
00070501101247
In Commercial Distribution

JOHNSON & JOHNSON CONSUMER INC.
00070501101247
GS1

1
002347102 *Terms of Use
light therapy acne mask
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
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
Red/blue light phototherapy unit A portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. This is a single-patient, reusable device.
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FDA Product Code

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Product Code Product Code Name
OLP Over-the-counter powered light based laser for acne
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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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
Storage Environment Humidity: between 0 and 60 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between .7 and 1.06 KiloPascal
Storage Environment Temperature: between 5 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

b6053cff-a2ad-4de5-9b2c-f0240ad22587
March 29, 2018
2
September 30, 2016
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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
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)361-8068
xxx@xxx.com
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