FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYNOSUREA ECLILITE AND ECLILITE U
K Number: K050080
·
Decision May 5, 2005
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
271
Applicant Total
98
Review Days
112
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
- CYNOSUREA ECLILITE AND ECLILITE U
- K Number
- K050080
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4630
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cynosure, Inc.
- Date Received
- January 13, 2005
- Decision Date
- May 5, 2005
- Product Code
- FTC
- 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 |
|---|---|---|---|
| FTC | Light, Ultraviolet, Dermatological | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FTC), ordered by most recent decision date.
Phototherapy System (DUV-COMBO)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Klär Lite (RCW-KL1000)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ultraviolet Phototherapy Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Cynosure, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K190678 | TempSure | Jul 24, 2019 | Substantially Equivalent |
| K182365 | TempSure System | Oct 24, 2018 | Substantially Equivalent |
| K173199 | PicoSure Workstation | Feb 7, 2018 | Substantially Equivalent |
| K171992 | SculpSure | Sep 26, 2017 | Substantially Equivalent |
| K171262 | TempSure | Sep 22, 2017 | Substantially Equivalent |
| K171111 | Sculpsure | Jun 13, 2017 | Substantially Equivalent |
| K160470 | SculpSure | Jul 21, 2016 | Substantially Equivalent |
| K160480 | PicoSure Workstation | May 17, 2016 | Substantially Equivalent |
| K150724 | SculpSure | Jul 1, 2015 | Substantially Equivalent |
| K150230 | SculpSure | May 15, 2015 | Substantially Equivalent |