Cleared Traditional

K790244 - CYSTOTOMES

K790244 is an FDA 510(k) clearance for CYSTOTOMES, manufactured by Visitec Co.. The device is a Class 1 Ophthalmic device with product code HNY cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K790244 · Visitec Co. · Ophthalmic device
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Feb 1979
Decision
45d
Days
Class 1
Risk

K790244 is an FDA 510(k) clearance for the CYSTOTOMES. Classified as Cystotome (product code HNY), Class I - General Controls.

Submitted by Visitec Co. (Mchenry, US). The FDA issued a Cleared decision on February 12, 1979 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - the FDA ophthalmic device framework. 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 Visitec Co. devices

FDA 510(k) Submission Details - K790244

510(k) Number K790244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1978
Decision Date February 12, 1979
Days to Decision 45 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 110d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

HNY Device Classification - Class 1, General Controls

Product Code HNY Cystotome
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.