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510(k) Data Aggregation
(189 days)
HERAEUS SURGICAL, INC.
The Cylindrically Diffusing Fiber is intended for soft tissue contact and coagulation for all cleared LaserSonics Nd: YAG soft tissue applications.
Cylindrically Diffusing Sterile Disposable Fiber
This document describes a premarket notification for a medical device, a cylindrically diffusing fiber for use with Nd:YAG lasers. However, the provided text does not contain any information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets acceptance criteria.
The document primarily focuses on:
- Regulatory Information: Company name, contact, device name, classification, and regulatory authority.
- Intended Use: Soft tissue contact and coagulation for specific laser applications.
- Predicate Device Comparison: Stating equivalence to the Dornier ThermaFocus 3600000 Fiber in terms of indications, materials, operation, and construction to justify 510(k) clearance.
Therefore, I cannot answer the questions about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies because this information is not present in the provided text.
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(57 days)
HERAEUS SURGICAL, INC.
Ask a specific question about this device
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