FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CANDELA MODEL MDL-1 LASER LITHOTRIPTOR
K Number: K863642
·
Decision Dec 3, 1986
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
60
Applicant Total
48
Review Days
77
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Basic Information
- Device Name
- CANDELA MODEL MDL-1 LASER LITHOTRIPTOR
- K Number
- K863642
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4480
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Candela Corp.
- Date Received
- September 17, 1986
- Decision Date
- December 3, 1986
- 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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| K Number | Device Name | ||
|---|---|---|---|
| K183452 | Vbeam Prima Laser System | Feb 1, 2019 | Substantially Equivalent |
| K140732 | CANDELA GENTLELASE FAMILY OF LASER SYSTEMS | Nov 7, 2014 | Substantially Equivalent |
| K140122 | CANDELA GENTLEMAX FAMILY OF LASER SYSTEM | May 9, 2014 | Substantially Equivalent |
| K133283 | CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS | Dec 26, 2013 | Substantially Equivalent |
| K112715 | CANDELA GENTLEMAX FAMILY OF LASERS | Oct 5, 2011 | Substantially Equivalent |
| K111144 | CANDELA GENTLELASE FAMILY OF LASERS | Jul 18, 2011 | Substantially Equivalent |
| K081324 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS | Jun 17, 2008 | Substantially Equivalent |
| K073534 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS | Apr 3, 2008 | Substantially Equivalent |
| K071469 | INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM | Aug 15, 2007 | Substantially Equivalent |
| K063800 | CANDELA FLUORESCENT PULSED LIGHT SYSTEM | Feb 5, 2007 | Substantially Equivalent |