FDA UDI Not in Commercial Distribution 🇺🇸 United States

Opti-Tip Treatment Kit

DI: 07290109145259 · Model: Opti-Tip Treatment Kit · LUMENIS LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
Opti-Tip Treatment Kit
Primary DI
07290109145259
Version / Model
Opti-Tip Treatment Kit
Company Name
LUMENIS LTD.
Labeler DUNS
600166524
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-07-25
Public Version
4
Public Version Date
2025-02-26
Public Version Status
Update
Public Device Record Key
fb0c071e-850a-4a1d-ab95-f75269c81fbe
Distribution End Date
2024-01-15

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
QIU Intense Pulsed Light Device For Managing Dry Eye

GMDN Terms

Code Name
60386 Intense pulsed light dry eye therapy unit

Identifiers

Type ID
Primary 07290109145259
Package 17290109145256