FDA UDI In Commercial Distribution 🇺🇸 United States

Q Switched Nd:YAG Laser machine

DI: 06971679500020 · Model: QLHF-02 · Beijing Nubway S&T Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Q Switched Nd:YAG Laser machine
Primary DI
06971679500020
Version / Model
QLHF-02
Company Name
Beijing Nubway S&T Co., Ltd.
Labeler DUNS
540583535
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-07-23
Public Version
4
Public Version Date
2025-05-16
Public Version Status
Update
Public Device Record Key
15ae3ebf-1c84-4b5d-8621-8191995fdaec

Device Characteristics

Single Use
No
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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GEX Powered Laser Surgical Instrument

GMDN Terms

Code Name
45221 Dermatological laser beam guiding handpiece

Identifiers

Type ID
Primary 06971679500020

Premarket Submissions

Submission Number Supplement Number
K193609 000