Oreeth

GUDID 06976971650091

IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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 regime.

Foshan Jindi Electric Appliance Co., Ltd.

Home-use intense pulsed light hair removal unit
Primary Device ID06976971650091
NIH Device Record Key8f121ee4-960c-4145-afd6-864f53543fa4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOreeth
Version Model NumberJD-TM002
Company DUNS702034523
Company NameFoshan Jindi Electric Appliance Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+8618316578883
Emailrenyigea@126.com
Phone+8618316578883
Emailrenyigea@126.com
Phone+8618316578883
Emailrenyigea@126.com
Phone+8618316578883
Emailrenyigea@126.com

Device Identifiers

Device Issuing AgencyDevice ID
GS106976971650091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OHTLight Based Over-The-Counter Hair Removal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-16
Device Publish Date2025-12-08

Devices Manufactured by Foshan Jindi Electric Appliance Co., Ltd.

06976971650091 - Oreeth2025-12-16IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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 regime.
06976971650091 - Oreeth2025-12-16 IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent r
06976971650107 - INNZA2025-12-16 IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent r
06976971650114 - WAVYTALK2025-12-16 IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent r
06976971650138 - INNZA2025-12-16 IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent r
06976971650121 - INNZA2025-12-03 IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent r
06976971650145 - INNZA2025-12-03 IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent r
06976971650152 - INNZA2025-12-03 IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent r
06976971650169 - INNZA2025-12-03 IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent r

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.