FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC
K Number: K854468
·
Decision Jun 20, 1986
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
12
Review Days
226
Basic Information
- Device Name
- PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC
- K Number
- K854468
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- MINNESOTA LASER CORP.
- Date Received
- November 6, 1985
- Decision Date
- June 20, 1986
- 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 MINNESOTA LASER CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K874255 | ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. | Jul 12, 1988 | Substantially Equivalent |
| K874253 | ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. | Jul 12, 1988 | Substantially Equivalent |
| K874254 | ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS | Mar 4, 1988 | Substantially Equivalent |
| K854473 | PORTALASE 300 CARBON DIOXIDE SURG LASER NEUROLOGIC | Jun 20, 1986 | Substantially Equivalent |
| K854471 | PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T | Feb 13, 1986 | Substantially Equivalent |
| K854472 | PORTALASE 300 CARBON DIOXIDE SURG LASER DERMATOLOG | Feb 11, 1986 | Substantially Equivalent |
| K854469 | PORTALASE 200 CARBON DIOXIDE SURG LASER DERMATOLOG | Feb 11, 1986 | Substantially Equivalent |
| K854470 | PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI | Feb 7, 1986 | Substantially Equivalent |
| K852694 | PORTALASE 200 CARBON SURGICAL LASER SYSTEM | Sep 30, 1985 | Substantially Equivalent for Some Indications |
| K852696 | FOR USE IN GENERAL & PLASTIC SURGERY & DERMATOLOGY | Sep 19, 1985 | Substantially Equivalent |