Device
An over-the-counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair cou...
Manufacturer
Silkn Beauty Ltd.
Silkn Beauty Ltd.
Model: Flash & Go Pro
Catalog: 7290019840428
DI: 07290019840428
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-06
Current Version: 2026-05-14
Description
An over-the-counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regimen.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
206b358a-15b8-4f6d-847d-e066ed7d73f2
Distribution Status:
In Commercial Distribution
DUNS Number:
473607052
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Box
Item #1 - Device ID:
17290019840425
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
4
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
07290019840428
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
07290019840428
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 47704
Name: Cosmetic red-light phototherapy system, home-use
Definition:
An assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in the home. It typically consists of an energy generator and an attached applicator to apply the energy to the skin. It is designed to be operated by the patient typically for self body hair removal, skin rejuvenation, vascular and pigmented lesion removal, wrinkle reduction, collagen renewal, acne clearance, and/or mild to moderate psoriasis care.
FDA Product Codes
ONF
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
OHT
Light Based Over-The-Counter Hair Removal
Premarket Submissions
Submission Number:
K141242
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #1 - Storage Handling Low - @attributes - Value:
50
Item #1 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #1 - Storage Handling High - @attributes - Value:
106
Item #1 - Storage Handling Type:
Handling Environment Atmospheric Pressure
Item #2 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #2 - Storage Handling Low - @attributes - Value:
70
Item #2 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #2 - Storage Handling High - @attributes - Value:
106
Item #2 - Storage Handling Type:
Handling Environment Atmospheric Pressure
Item #3 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #3 - Storage Handling Low - @attributes - Value:
10
Item #3 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #3 - Storage Handling High - @attributes - Value:
90
Item #3 - Storage Handling Type:
Storage Environment Humidity
Item #4 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #4 - Storage Handling Low - @attributes - Value:
30
Item #4 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #4 - Storage Handling High - @attributes - Value:
75
Item #4 - Storage Handling Type:
Handling Environment Humidity
Item #5 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #5 - Storage Handling Low - @attributes - Value:
-40
Item #5 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #5 - Storage Handling High - @attributes - Value:
70
Item #5 - Storage Handling Type:
Storage Environment Temperature
Item #6 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #6 - Storage Handling Low - @attributes - Value:
10
Item #6 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #6 - Storage Handling High - @attributes - Value:
35
Item #6 - Storage Handling Type:
Handling Environment Temperature