Panels › General, Plastic Surgery › Product code ONF · Class 2
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Regulation 878.4810
1510(k)s in 12 months (74 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in ONF
| Company | 510(k)s | Recalls |
|---|---|---|
| Shaser, Inc. | 9 | 0 |
| Venus Concept , Ltd. | 3 | 0 |
| Beijing Adss Development Co., Ltd. | 2 | 0 |
| Beijing Globalipl Development Co., Ltd. | 2 | 0 |
| El.En S.P.A. | 2 | 0 |
| Shangdong Huamei Technology Co., Ltd. | 2 | 0 |
| Smedtrum Medical Technology Co., Ltd. | 2 | 0 |
| Syneron Beauty , Ltd. | 2 | 0 |
| Advanced Medical Photonics | 1 | 0 |
| Ahwon Medi Instrument Co., Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 13, 2013 | K130015 | SHASER V-MINI HAIR REMOVAL SYSTEM Shaser, Inc. | ONF |
| Apr 2, 2013 | K123860 | INMODE SR IPL DEVICE Inmode MD , Ltd., IL | ONF |
| Mar 4, 2013 | K123889 | ACLEARA, THERACLEAR Theravant Corporation | ONF |
| Feb 11, 2013 | K123435 | IPL THERAPY SYSTEM Beijing Sincoheren S&T Development Co, Ltd., CN | ONF |
| Jan 22, 2013 | K122995 | INTENSE PULSED LIGHT (IPL) SYSTEMS Beijing Kes Biology Technology Co., Ltd., CN | ONF |
| Jan 10, 2013 | K123845 | ME Syneron Beauty , Ltd. | ONF |
| Oct 12, 2012 | K121598 | ME HAIR2GO Syneron Medical, Ltd. | ONF |
| Jun 5, 2012 | K121515 | ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM Solta Medical, Inc. | ONF |
| May 25, 2012 | K120080 | SHASER HRS2 HAIR REMOVAL SYSTEM Shaser, Inc. | ONF |
| Sep 29, 2011 | K111350 | MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM Medicam, Inc., CA | ONF |
| May 18, 2011 | K103560 | SHASER IPL HAIR REMOVAL SYSTEM Shaser, Inc. | ONF |
| Mar 8, 2011 | K101901 | IPL THERAPY SYSTEM Beijing Starlight Science & Technology Development, CN | ONF |
| Jan 18, 2011 | K093627 | IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650 Shanghai Apolo Medical Technologies Co., Ltd. | ONF |
| Jan 14, 2011 | K102857 | AHWON'S IPL SYSTEM Ahwon Medi Instrument Co., Ltd. | ONF |
| May 21, 2010 | K093168 | MEDIFLASH AND ESTEFLASH Dermeo | ONF |
| Mar 10, 2010 | K100053 | MATTIOLI PULSE TWO/THREE PLUS FAMILY Mattioli Engineering Corp. | ONF |
| Mar 5, 2010 | K092326 | SMOOTHCOOL Jeisys Medical, Inc. | ONF |
| Jan 5, 2010 | K093465 | FUSION SYSTEM Eclipsemed Global, Inc. | ONF |
| Nov 16, 2009 | K091664 | GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C Shenzhen Gsd Tech Co., Ltd., CN | ONF |
| Oct 7, 2009 | K090724 | OR-LIGHT Yperion Technology, FR | ONF |
| Aug 27, 2009 | K082040 | MINISILK FT El.En Electronic Engineering Spa, IT | ONF |
| Jun 17, 2009 | K090837 | STRATAPULSE TS AND STRATAPULSE Advanced Medical Photonics | ONF |
| Jun 10, 2009 | K090399 | TRIOS SYSTEM Viora , Ltd. | ONF |
| Sep 12, 2008 | K082484 | ACCELAWAVE SYSTEM Genesis Biosystems, Inc. | ONF |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.