FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM
K Number: K945054
·
Decision Nov 28, 1994
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
7
Review Days
45
Basic Information
- Device Name
- ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM
- K Number
- K945054
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- CYTOCARE, INC.
- Date Received
- October 14, 1994
- Decision Date
- November 28, 1994
- 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 CYTOCARE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K954321 | ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION) | Oct 13, 1995 | Substantially Equivalent |
| K952698 | ENDOCARE ELECTROSURGICAL HANDPIECE | Aug 14, 1995 | Substantially Equivalent |
| K952587 | ENDOCARE MONOPOLAR ELECTRODES | Jul 17, 1995 | Substantially Equivalent |
| K942299 | ENDOCARE CRYOTHERAPY SYSTEM | Jan 19, 1995 | Substantially Equivalent |
| K934211 | CYTOCARE DIODE LASER SYSTEM | May 17, 1994 | Substantially Equivalent |
| K921708 | CYTOCARE LASER CATHETER FOR UROLOGY | Oct 1, 1992 | Substantially Equivalent |