FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LASESONICS LOW POWER CO2 LASER SYSTEM
K Number: K953917
·
Decision Oct 26, 1995
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
8
Review Days
66
Basic Information
- Device Name
- LASESONICS LOW POWER CO2 LASER SYSTEM
- K Number
- K953917
- 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
- HERAEUS SURGICAL, INC.
- Date Received
- August 21, 1995
- Decision Date
- October 26, 1995
- 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 HERAEUS SURGICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K960636 | LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER | Aug 21, 1996 | Substantially Equivalent |
| K955734 | LASERSONICS PARASCAN DOSIMETER DEVICE | Feb 13, 1996 | Substantially Equivalent |
| K951215 | LASERSONICS ULTRALINE III STERILE DISPOSABLE FIBER | Apr 18, 1995 | Substantially Equivalent |
| K943716 | LASERSONICS SURGICAL LASER SYSTEMS AND ACCESSORIES | Mar 14, 1995 | Substantially Equivalent |
| K944346 | LASERSONICS RADIANCE DIODE LASER SYSTEMS AND ACCESSORIES | Nov 8, 1994 | Substantially Equivalent |
| K935604 | LASERSONICS TISSUE MORCELLATOR SET | Mar 23, 1994 | Substantially Equivalent |
| K935775 | LASERSONICS CLEARPULSE MODELS 50, 70 & 100 CO2 SURGICAL LASER SYSTEMS | Mar 1, 1994 | Substantially Equivalent |