MELIDE FIBEROPTIC LIGHT
FDA 510(k) clearance K051786 · decided 2005-08-15
Clearance details
- K-number
- K051786
- Device name
- MELIDE FIBEROPTIC LIGHT
- Applicant
- Designs For Vision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-07-01
- Decision date
- 2005-08-15
- Days to decision
- 45 days
- Clearance type
- Special
- Product code
- FST
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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| CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST (K093386) | Bfw, Inc. | 2010-01-28 |
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Recalls involving this device
No recalls on record reference this clearance.