FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROLASE CO2 LASER MICROMANIPULATOR
K Number: K891126
·
Decision Mar 17, 1989
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
11
Review Days
14
Basic Information
- Device Name
- MICROLASE CO2 LASER MICROMANIPULATOR
- K Number
- K891126
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- XIMED MEDICAL SYSTEMS
- Date Received
- March 3, 1989
- Decision Date
- March 17, 1989
- 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 |
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Other Clearances by XIMED MEDICAL SYSTEMS
| K Number | Device Name | ||
|---|---|---|---|
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| K933757 | HAND-HELD IRRIGATION PUMP | Aug 26, 1994 | Substantially Equivalent |
| K933458 | SURGICAL TROCARS | May 5, 1994 | Substantially Equivalent |
| K922714 | UNIVERSAL IRRIGATION & SUCTION TUBING SET | Aug 3, 1993 | Substantially Equivalent |
| K922523 | BIPOLAR ELECTROSURGICAL PROBES & INSTRUMENTS | Sep 23, 1992 | Substantially Equivalent |
| K903812 | ELECTROPROBE SINGLE-USE SURGICAL PROBE | Sep 20, 1990 | Substantially Equivalent |
| K900463 | LASER DELIVERY SYSTEMS, FIBEROPTICS & CONTACT TIPS | Mar 22, 1990 | Substantially Equivalent |
| K892933 | INFRALASE-LASERGUIDE DELIVERY SYSTEM | Jun 22, 1989 | Substantially Equivalent |
| K890775 | INFRALASE - LASERGUIDE DELIVERY SYSTEM | Apr 21, 1989 | Substantially Equivalent |