Cleared Traditional

SOLEO SUNBED (K844788) - FDA 510(k) Clearance

K844788 · Hapro International B.V. · General & Plastic Surgery device
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Feb 1985
Decision
59d
Days
-
Risk

K844788 is an FDA 510(k) clearance for the SOLEO SUNBED.

Submitted by Hapro International B.V. (Memphis, US). The FDA issued a Cleared decision on February 7, 1985 after a review of 59 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hapro International B.V. devices

Submission Details

510(k) Number K844788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1984
Decision Date February 07, 1985
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 115d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -