FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
BLUESHINE'S GOLD SERIES
K Number: K110375
·
Decision Feb 23, 2012
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
18
Applicant Total
3
Review Days
379
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BLUESHINE'S GOLD SERIES
- K Number
- K110375
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Blueshine Srl
- Date Received
- February 9, 2011
- Decision Date
- February 23, 2012
- Product Code
- PDZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PDZ), ordered by most recent decision date.
Medicell Mycosis Laser (MCML24004)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Onycho Laser V
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TFX-LT2000 Therapy Light
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AF Laser
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
REMY Medical Therapy Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LunulaLaser
FDA 510(k)
FDA Class 2
·General, Plastic Surgery