FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANDELA DYNAMIC COOLING DEVICE
K Number: K951033
·
Decision Aug 15, 1996
Classifications
1
FEI Numbers
377
Registration Numbers
377
Same Product Code
81
Applicant Total
43
Review Days
528
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Basic Information
- Device Name
- ANDELA DYNAMIC COOLING DEVICE
- K Number
- K951033
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5710
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Candela Laser Corp.
- Date Received
- March 6, 1995
- Decision Date
- August 15, 1996
- Product Code
- IMD
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IMD | Pack, Hot Or Cold, Disposable | FDA class 1 | Physical Medicine |
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Other Clearances by Candela Laser Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K955662 | CANDELA Q-SWITCHED ALEXANDRITE LASERS | Jun 14, 1996 | Substantially Equivalent |
| K955011 | CANDELA HCS 2000 URETHERAL WARMER CATHETER | Apr 3, 1996 | Substantially Equivalent |
| K954872 | CANDELA CRYO-PROBE HOLDER | Feb 5, 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 |