Celluma CDLX-001

GUDID 00850523007129

3 mode full body panel

BIOPHOTAS, INC.

Blue/red/infrared phototherapy lamp
Primary Device ID00850523007129
NIH Device Record Keyae0a3b12-78f9-44a6-a079-ad98debb8899
Commercial Distribution StatusIn Commercial Distribution
Brand NameCelluma
Version Model NumberDELUX C/US
Catalog NumberCDLX-001
Company DUNS063400364
Company NameBIOPHOTAS, INC.
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850523007129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLPOver-The-Counter Powered Light Based Laser For Acne

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-07-07
Device Publish Date2020-06-11

On-Brand Devices [Celluma]

00850523007402Home
00850523007303Elite C/US
00850523007204Lite C/US
00850523007105Pro C/US
008505230076002-mode large panel
00850523007501Hand held device 3-mode
008505230071813 mode small panel
008505230071743 mode large panel
008505230071433 mode full body panel
008505230071293 mode full body panel
008505230070751 mode large panel
008505230070512 mode small panel
008505230070371-mode small panel
008505230071363 mode device. Hair, Wrinkles, Aches & Pains

Trademark Results [Celluma]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CELLUMA
CELLUMA
85475731 4299058 Live/Registered
BIOPHOTAS, INC.
2011-11-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.