Regenesis 3

GUDID G253R30

red/infrared light phototherapy unit

Ochs Labs LLC

Red/infrared light phototherapy unit
Primary Device IDG253R30
NIH Device Record Key2d472391-fa78-4d58-b73f-a0825786d621
Commercial Distribution StatusIn Commercial Distribution
Brand NameRegenesis 3
Version Model Number1
Company DUNS081152913
Company NameOchs Labs LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG253R30 [Primary]

FDA Product Code

ILYLamp, Infrared, Therapeutic Heating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-12
Device Publish Date2025-02-04

Devices Manufactured by Ochs Labs LLC

G253R30 - Regenesis 32025-02-12red/infrared light phototherapy unit
G253R30 - Regenesis 32025-02-12 red/infrared light phototherapy unit
G253LW30 - LENS2023-10-12 NKPW Psychophysiological biofeedback system A computerized device assembly designed for analysis and real-time feedback (biofeed

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