FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MDL-1 LASERTRIPTER(TM)
K Number: K885255
·
Decision Jun 1, 1989
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
60
Applicant Total
43
Review Days
160
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Basic Information
- Device Name
- MDL-1 LASERTRIPTER(TM)
- K Number
- K885255
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4480
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Candela Laser Corp.
- Date Received
- December 23, 1988
- Decision Date
- June 1, 1989
- Product Code
- FFK
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FFK | Lithotriptor, Electro-Hydraulic | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Candela Laser Corp.
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|---|---|---|---|
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| 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 |