POWERLED SURGICAL LIGHT SYSTEM
FDA 510(k) clearance K070442 · decided 2007-03-16
Clearance details
- K-number
- K070442
- Device name
- POWERLED SURGICAL LIGHT SYSTEM
- Applicant
- Maquet S.A.
- Decision
- Substantially Equivalent
- Date received
- 2007-02-15
- Decision date
- 2007-03-16
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- FSY
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Leo Minor (K142984) | Sunnex, Inc. | 2014-10-29 |
| CLAVEGUARD FREEDOM SURGICAL LIGHT (K142076) | Dickson & Dickson Healthcare (Us), Inc. | 2014-09-30 |
| MI-750 PROCEDURAL/MINOR SURGICAL LIGHT (K140812) | Medical Illumination International, Inc. | 2014-08-07 |
| ZF 720 (K132551) | Umbel Corporation | 2014-06-30 |
| VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES (K140930) | Convida Healthcare & Systems Corporation | 2014-06-09 |
| MACH LED 2SC (K140460) | Dr. Mach GmbH & Co. KG | 2014-04-03 |
| MACH LED 2MC (K140461) | Dr. Mach GmbH & Co. KG | 2014-04-03 |
| VISUM BLADE LED SURGICAL LIGHTING SYSTEM (K132747) | Stryker Communications | 2013-12-30 |
| VIDA LED SURGICAL LIGHTING SYSTEM (K132307) | Convida Healthcare & Systems Corporation | 2013-11-05 |
| AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS (K131893) | Ajw Technology Consultants, Inc. | 2013-10-30 |
| ORICARE L2700 (K122875) | Oricare, Inc. | 2012-12-18 |
| CHROMOPHARE F 628 AND F 528 (K120392) | Berchtold GmbH & Co. KG | 2012-02-16 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers E recall (Z-0763-2024) | Getinge Usa Sales Inc | 2024-01-19 |
| The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended recall (Z-1990-2015) | Maquet Cardiovascular Us Sales, Llc | 2015-07-07 |