LIGHTSOURCE OR ILLUMINATOR
FDA 510(k) clearance K961074 · decided 1996-04-30
Clearance details
- K-number
- K961074
- Device name
- LIGHTSOURCE OR ILLUMINATOR
- Applicant
- Cuda Products Co.
- Decision
- Substantially Equivalent
- Date received
- 1996-03-18
- Decision date
- 1996-04-30
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- FSS
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Jacksonville, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cuda Products Co.
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 |
|---|---|---|
| ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M) (K091246) | Trumpf Medizin Systeme GmbH + Co. KG | 2009-09-28 |
| NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8 (K003489) | Medical Illumination International, Inc. | 2001-02-02 |
| AESCULAP XENON LIGHT SOURCE (K984124) | Aesculap, Inc. | 1999-02-01 |
| CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE (K981962) | Cuda Products Co. | 1998-08-18 |
| VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR (K981821) | Angiolaz, Inc. | 1998-07-29 |
| CERMAX300 LIGHTSOURCE (K981469) | Cuda Products Co. | 1998-07-09 |
| XENON 300MX (K980044) | Perkinelmer Optoelectronics | 1998-04-03 |
| HANAULUX BLUE 80 HOSPITAL (K970886) | Heraeus Med GmbH | 1997-04-16 |
| Q-5000 (K961971) | Stryker Endoscopy | 1996-06-28 |
| TRI*STAR (K930711) | Light Technology Systems | 1993-07-30 |
| AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT (K910942) | Mdt Biologic Co. | 1991-06-11 |
| MODEL FEL5100 FLOOR LIGHT (K895950) | F.W. Lang Co. | 1989-10-31 |
Recalls involving this device
No recalls on record reference this clearance.