FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X
K Number: K002228
·
Decision Oct 6, 2000
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
10
Review Days
74
Basic Information
- Device Name
- PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X
- K Number
- K002228
- 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
- PARADIGM MEDICAL INDUSTRIES, INC.
- Date Received
- July 24, 2000
- Decision Date
- October 6, 2000
- Product Code
- GEX
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEX), ordered by most recent decision date.
AviClear Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Pastelle
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SurgiLight 1470 Diode Laser System (Model:Halo)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AuroLase® System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Diode laser device (RF3120-BI)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by PARADIGM MEDICAL INDUSTRIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K050980 | ULTRASONIC BIO-MICROSCOPE, MODEL P60 | May 26, 2005 | Substantially Equivalent |
| K023245 | BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01 | Oct 21, 2002 | Substantially Equivalent |
| K003318 | PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X | May 22, 2001 | Substantially Equivalent |
| K003141 | UBM PLUS, MODEL P45 | Dec 5, 2000 | Substantially Equivalent |
| K981109 | QUITETIP | Jun 9, 1998 | Substantially Equivalent |
| K974719 | PHACOPAK | Jan 20, 1998 | Substantially Equivalent |
| K971795 | AUTOMATED CHAMBER MAINTENANCE MODULE | Jul 14, 1997 | Substantially Equivalent |
| K970887 | BLOOD FLOW ANALYZER | Jun 17, 1997 | Substantially Equivalent |
| K953447 | PRECISIONIST THIRTY THOUSAND | Oct 13, 1995 | Substantially Equivalent |