AccessGUDID - DEVICE: OptiLight IPL Module Kit (07290109144740)

GUDID

Device Identifier (DI) Information

Brand Name: OptiLight IPL Module Kit
Version or Model: OptiLight IPL Module Kit
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: LUMENIS LTD.

Primary DI Number: 07290109144740
Issuing Agency: GS1
Commercial Distribution End Date: August 10, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 600166524 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60386	Intense pulsed light dry eye therapy unit	A portable mains electricity (AC-powered) device intended to treat meibomian blepharitis (dry eye syndrome) by targeting the skin surrounding the meibomian glands (around the eyelid) with intense pulsed light (IPL). It consists of a generator connected to a light-emitting handpiece, and typically includes skin contact gel and light shielding safety glasses. It is intended to be operated by a healthcare professional in a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QIU	Intense Pulsed Light Device For Managing Dry Eye

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6ff71435-bdbd-47c9-98f9-b49374836022
Public Version Date: February 26, 2025
Public Version Number: 4
DI Record Publish Date: July 25, 2021