FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CANDELA CRYO-PROBE HOLDER
K Number: K954872
·
Decision Feb 5, 1996
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
261
Applicant Total
43
Review Days
104
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CANDELA CRYO-PROBE HOLDER
- K Number
- K954872
- 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
- October 24, 1995
- Decision Date
- February 5, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEH), ordered by most recent decision date.
ERBECRYO 2 Cryosurgical Unit and Accessories
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
XSense Cryoablation System with CryoProbes
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Dr. Yglo Skin Tag Remover
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Candela Laser Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K951033 | ANDELA DYNAMIC COOLING DEVICE | Aug 15, 1996 | Substantially Equivalent |
| K955662 | CANDELA Q-SWITCHED ALEXANDRITE LASERS | Jun 14, 1996 | Substantially Equivalent |
| K955011 | CANDELA HCS 2000 URETHERAL WARMER CATHETER | Apr 3, 1996 | Substantially Equivalent |
| K954934 | CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE | Feb 2, 1996 | Substantially Equivalent |
| 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 |