FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELIOS DIODE OPHTHALMIC LASER
K Number: K921320
·
Decision Jul 2, 1992
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
15
Review Days
105
Basic Information
- Device Name
- ELIOS DIODE OPHTHALMIC LASER
- K Number
- K921320
- 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
- MARCO OPHTHALMIC, INC.
- Date Received
- March 19, 1992
- Decision Date
- July 2, 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 MARCO OPHTHALMIC, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K943234 | MS-30 AUTOMATIC PERIMETER | Jul 27, 1994 | Substantially Equivalent |
| K930438 | MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS | Aug 9, 1993 | Substantially Equivalent |
| K930442 | MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS | Aug 9, 1993 | Substantially Equivalent |
| K930444 | MARCO STANDARD KERATOMETERS | Aug 9, 1993 | Substantially Equivalent |
| K930437 | MARCO STANDARD RADIUSGAUGES | Aug 9, 1993 | Substantially Equivalent |
| K930439 | MARCO SURGISCOPE OPERATION MICROSCOPES | Jul 22, 1993 | Substantially Equivalent |
| K930447 | MARCO H AND TS-1 INSTRUMENT TABLES | Jul 6, 1993 | Substantially Equivalent |
| K930449 | MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR | Jul 6, 1993 | Substantially Equivalent |
| K930446 | MARCO TRIAL SETS | Jul 6, 1993 | Substantially Equivalent |
| K930443 | MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE | Jul 6, 1993 | Substantially Equivalent |