Product code FTA
- Device name
- Light, Surgical, Accessories
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4580
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150532 | Universal Light Handle Cover, Light Handle Cover | Key Surgical, Inc. | 2015-09-22 |
| K142386 | Operating Room Light Handle Adapter | Litex Manufacturing, Inc. | 2014-09-29 |
| K133554 | SURGICAL LIGHT HANDLE COVER | Microtek Medical, Inc. an Ecolab Company | 2014-04-08 |
| K133413 | IDSS SLC | Black Diamond Video | 2014-01-07 |
| K112133 | OASYS SURGICAL LIGHT CONTROLLER | Oasys Healthcare | 2012-03-01 |
| K102791 | EASYSUITE SURGICAL LIGHT CONTROL (ESLC) | Image Stream Medical, Inc. | 2010-11-23 |
| K081698 | MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) | Image Stream Medical, Inc. | 2008-07-30 |
| K053321 | LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER | Xodus Medical, Inc. | 2006-01-19 |
| K051505 | SCB/STERIS OR-LIGHT INTERFACE BOX | KARL STORZ Endoscopy-America, Inc. | 2005-08-11 |
| K023704 | KSEA SCB ACC CONTROL | KARL STORZ Endoscopy-America, Inc. | 2003-01-30 |
| K020640 | KSEA SCB MEDIA CONTROL | KARL STORZ Endoscopy-America, Inc. | 2002-05-28 |
| K020304 | DISPOSABLE LIGHT HANDLE AND ADAPTOR | Aspen Surgical Products, Inc. | 2002-02-14 |
| K993089 | DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER | Deroyal Cardiovascular, Inc. | 1999-10-14 |
| K954940 | MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE | Mdt Biologic Co. | 1996-01-17 |
| K935102 | SATURN LIGHT | Burton Medical Products Corp. | 1994-06-27 |
| K915068 | PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER | American Medical Mfg., Inc. | 1992-02-06 |
| K901154 | MICROTEK'S SURGICAL LAMP HANDLE & COVER | Microbio-Medics, Inc. | 1990-03-20 |
| K894397 | WELCON LIGHT HANDLE | Welcon, Inc. | 1989-08-10 |
| K890866 | TC SYSTEM-HANDLE | Transmedical Corp. | 1989-03-14 |
| K890867 | TC SYSTEM-COVER | Transmedical Corp. | 1989-03-14 |
| K890539 | SURE COUNT LIGHT HANDLE COVER | Kleen Test Products | 1989-02-27 |
| K882132 | LIGHT, SURGICAL ACCESSORIES | Charles Polo & Co., Inc. | 1988-06-15 |
| K871034 | LCA 2000 | Vistek Corp. | 1987-04-10 |
| K862010 | CHICK SURGICAL LIGHT | Professional Medical Products, Inc. | 1986-06-09 |
| K810292 | CAM-WRAP | Medline Industries, Inc. | 1981-03-04 |
| K780162 | DIGAPHOT PHOTOTHERAPY METER MODEL PT 145 | Cavitron Corp. | 1978-03-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10748426144560 | Medline-Microtek | Microtek Medical LLC | 2026-02-18 |
| 10724995245457 | HexaLux | STERIS CORPORATION | 2025-05-05 |
| 10197344006915 | Medline | MEDLINE INDUSTRIES, INC. | 2023-11-05 |
| 50885380183001 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-08-11 |
| 50885380182998 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-08-11 |
| 10193489003093 | MEDLINE INDUSTRIES | MEDLINE INDUSTRIES, INC. | 2021-11-03 |
| 10193489003109 | MEDLINE INDUSTRIES | MEDLINE INDUSTRIES, INC. | 2021-11-03 |
| 10193489005875 | MEDLINE INDUSTRIES | MEDLINE INDUSTRIES, INC. | 2021-11-03 |
| G018DLH010 | Physician's Choice | Supply Line International Medical, LLC | 2021-08-05 |
| 10885380121937 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2020-10-02 |
| 10724995172562 | NA | STERIS CORPORATION | 2020-05-14 |
| 10865082000174 | SurgiLight Disposable Handle Assembly | BihlerMed, L.L.C. | 2019-08-09 |
| 10841736110567 | Center Focus Handle | SKYTRON LLC | 2017-03-23 |
| 10612479202235 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479202174 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479202204 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10884521547971 | Devon | Cardinal Health, Inc. | 2016-09-24 |
| 10884521547995 | Devon | Cardinal Health, Inc. | 2016-09-24 |
| 10884521548039 | Devon | Cardinal Health, Inc. | 2016-09-24 |
| 10884521548077 | Devon | Cardinal Health, Inc. | 2016-09-24 |
| 10884521548084 | Devon | Cardinal Health, Inc. | 2016-09-24 |
| 10841736100278 | Center Focus Handle | SKYTRON LLC | 2016-09-19 |
| 10809160033999 | AVID TruCustom | AVID MEDICAL, INC. | 2016-09-15 |
| 10885380000683 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-01 |
| 10809160003206 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |
| 10809160021316 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |
| 10809160021330 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |
| 10809160024027 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |
| 10809160002766 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |
| 10809160002506 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |