FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS
K Number: K133283
·
Decision Dec 26, 2013
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
47
Review Days
62
Basic Information
- Device Name
- CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS
- K Number
- K133283
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CANDELA CORP.
- Date Received
- October 25, 2013
- Decision Date
- December 26, 2013
- Product Code
- GEX
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by CANDELA CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K140732 | CANDELA GENTLELASE FAMILY OF LASER SYSTEMS | Nov 7, 2014 | Substantially Equivalent |
| K140122 | CANDELA GENTLEMAX FAMILY OF LASER SYSTEM | May 9, 2014 | 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 |
| K063074 | CANDELA 3630 LASER SYSTEM | Dec 27, 2006 | Substantially Equivalent |
| K063072 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND 1064 ND:YAG HANDPIECE ACCESSORIES | Dec 20, 2006 | Substantially Equivalent |