FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS
K Number: K874254
·
Decision Mar 4, 1988
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
18
Applicant Total
12
Review Days
136
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Basic Information
- Device Name
- ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS
- K Number
- K874254
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4500
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Minnesota Laser Corp.
- Date Received
- October 20, 1987
- Decision Date
- March 4, 1988
- Product Code
- LLO
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| LLO | Laser, Neodymium:Yag, Pulmonary Surgery | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLO), ordered by most recent decision date.
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LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE
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MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS
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SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE
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MODEL 5050 SURGILASER FOR PULMONARY USE
FDA 510(k)
FDA Class 2
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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 |
| K854473 | PORTALASE 300 CARBON DIOXIDE SURG LASER NEUROLOGIC | Jun 20, 1986 | Substantially Equivalent |
| K854468 | PORTALASE 200 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 |