FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CANDELA HCS 2000 URETHERAL WARMER CATHETER
K Number: K955011
·
Decision Apr 3, 1996
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
261
Applicant Total
43
Review Days
154
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Basic Information
- Device Name
- CANDELA HCS 2000 URETHERAL WARMER CATHETER
- K Number
- K955011
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4350
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Candela Laser Corp.
- Date Received
- November 1, 1995
- Decision Date
- April 3, 1996
- Product Code
- GEH
- 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 |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Candela Laser Corp.
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|---|---|---|---|
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| K953412 | CANDELA MODEL PLTL-1 LASER SYSTEM | Oct 24, 1995 | Substantially Equivalent |
| K953294 | CANDELA CRYOSYSTEM CS-5 | Oct 18, 1995 | Substantially Equivalent |
| K950831 | ALEXLAZR | May 26, 1995 | Substantially Equivalent |
| K946386 | CANDELA RUBY LAZE Q-SWITCHED RUBY LASER | Mar 24, 1995 | Substantially Equivalent |
| K950661 | CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE | Mar 10, 1995 | Substantially Equivalent |
| K943292 | CANDELA SPTL VARIABLE PULSE/TUNABLE PULSED DYE LASERS | Mar 9, 1995 | Substantially Equivalent |