FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR
K Number: K895837
·
Decision Dec 14, 1989
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
8
Review Days
72
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Basic Information
- Device Name
- MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR
- K Number
- K895837
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medical Laser, Inc.
- Date Received
- October 3, 1989
- Decision Date
- December 14, 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 Medical Laser, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K913136 | LASER ENDOSCOPE DISC DECOMPRESSION KITS | Nov 1, 1991 | Unknown |
| K912265 | MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000 | Oct 10, 1991 | Substantially Equivalent |
| K912447 | SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200 | Sep 27, 1991 | Substantially Equivalent |
| K912089 | MODIFIED SERIES 2100 ENDOSCOPES | Aug 12, 1991 | Substantially Equivalent |
| K901464 | MEDILASE SERIES 2200 ENDOSCOPE | Aug 7, 1990 | Substantially Equivalent |
| K900894 | MEDILASE SERIES 2100 ENDOSCOPE | Jun 22, 1990 | Substantially Equivalent |
| K900380 | MEDILASE 5010 ENDOSCOPE CONSOLE | May 15, 1990 | Substantially Equivalent |