MACH LED 2MC
FDA 510(k) clearance K140461 · decided 2014-04-03
Clearance details
- K-number
- K140461
- Device name
- MACH LED 2MC
- Applicant
- Dr. Mach GmbH & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 2014-02-24
- Decision date
- 2014-04-03
- Days to decision
- 38 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
- Norderstedt, Schleswig-Holstein, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Dr. Mach GmbH & Co. KG
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| 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 |
| TRULIGHT 5520 AND TRULIGHT 5320 (K102758) | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2010-10-26 |
Recalls involving this device
No recalls on record reference this clearance.