FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARBON DIOXIDE CO2 LASER
K Number: K915656
·
Decision Apr 10, 1992
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
9
Review Days
114
Basic Information
- Device Name
- CARBON DIOXIDE CO2 LASER
- K Number
- K915656
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ION LASER TECHNOLOGY
- Date Received
- December 18, 1991
- Decision Date
- April 10, 1992
- 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 ION LASER TECHNOLOGY
| K Number | Device Name | ||
|---|---|---|---|
| K974369 | APOLLO 9500 | Jan 6, 1998 | Substantially Equivalent |
| K964524 | ILT ARGON HP | Mar 18, 1997 | Substantially Equivalent |
| K953898 | ACL-5500 PRECISION CURING UNIT (PCU) | Feb 15, 1996 | Substantially Equivalent |
| K954460 | ILT SURGICAL LASER | Dec 18, 1995 | Substantially Equivalent |
| K950351 | CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION) | Mar 24, 1995 | Substantially Equivalent |
| K944206 | GENESIS 2000 | Oct 11, 1994 | Substantially Equivalent |
| K944317 | GENESIS 2000 | Oct 11, 1994 | Substantially Equivalent |
| K914726 | ILT CO2 SURGICAL LASER FOR ORAL SOFT TISSUE PROCED | Dec 17, 1991 | Substantially Equivalent |