FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
MEDILAS 2
K Number: K853580
·
Decision Feb 13, 1986
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
4
Applicant Total
24
Review Days
171
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Basic Information
- Device Name
- MEDILAS 2
- K Number
- K853580
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Endo Lase, Inc.
- Date Received
- August 26, 1985
- Decision Date
- February 13, 1986
- Product Code
- LKW
- Advisory Committee
- Unknown
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| LKW | Laser, Neurosurgical | FDA class 3 | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKW), ordered by most recent decision date.
ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY
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·Unknown
MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA.
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·Unknown
25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY
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FDA Class 3
·Unknown
MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL
FDA 510(k)
FDA Class 3
·Unknown
Other Clearances by Endo Lase, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K853900 | ENDO-LASE CD40 FOR NEUROSURGERY | Jun 18, 1986 | Substantially Equivalent |
| K853878 | ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY | May 2, 1986 | Substantially Equivalent |
| K855093 | MEDILAS 2 ND:YAG LASER SURGERY SYSTEM | Feb 21, 1986 | Substantially Equivalent |
| K853903 | ENDO-LASE CD40 CO2 FOR GYNECOLOGY | Feb 21, 1986 | Substantially Equivalent |
| K853876 | ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY | Feb 21, 1986 | Substantially Equivalent |
| K853877 | ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY | Feb 19, 1986 | Substantially Equivalent |
| K853901 | ENDO-LASE CD 40 FOR DERMATOLOGY | Feb 19, 1986 | Substantially Equivalent |
| K860152 | MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY | Feb 5, 1986 | Substantially Equivalent |
| K853902 | ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY | Jan 9, 1986 | Substantially Equivalent |
| K853875 | ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY | Jan 9, 1986 | Substantially Equivalent |