Atlas FDA

Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers

FDA 510(k) clearance K251759 · decided 2025-07-09

Clearance details

K-number
K251759
Device name
Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2025-06-09
Decision date
2025-07-09
Days to decision
30 days
Clearance type
Special
Product code
GEX
Device class
2
Regulation number
878.4810
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Marlborough, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

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