Cleared Traditional

K870439 - LOOK IRRIGATING CYSTOTOMES

K870439 is an FDA 510(k) clearance for LOOK IRRIGATING CYSTOTOMES, manufactured by Look, Inc.. The device is a Class 1 Ophthalmic device with product code HNY cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K870439 · Look, Inc. · Ophthalmic device
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Feb 1987
Decision
17d
Days
Class 1
Risk

K870439 is an FDA 510(k) clearance for the LOOK IRRIGATING CYSTOTOMES. Classified as Cystotome (product code HNY), Class I - General Controls.

Submitted by Look, Inc. (Boston, US). The FDA issued a Cleared decision on February 20, 1987 after a review of 17 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.

FDA 510(k) Submission Details - K870439

510(k) Number K870439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1987
Decision Date February 20, 1987
Days to Decision 17 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
93d faster than avg
Panel avg: 110d · This submission: 17d
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.

Regulatory Peers - HNY Cystotome

All 19
Devices cleared under the same product code (HNY) and FDA review panel - the closest regulatory comparables to K870439.
PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME
K875001 · Advanced Surgical Products, Inc. · Apr 1988
VAN DELLEN IRRIGATING CYSTOTOME
K873163 · Van Dellen, Ltd. · Sep 1987
CAPSULECTOMER CYSTOTOME
K871365 · Noetix, Inc. · Apr 1987
MECHANICAL CYSTITOME
K862709 · Rudolph Beaver, Inc. · Aug 1986
PRECISION - COSMET CAPSULE COUPEUR
K852934 · Precision-Cosmet Co., Inc. · Aug 1985
CLAYMAN-PAREL CAPSULE COUPEUR
K841101 · Miami Eye Technology, Inc. · May 1984
K870439 · LOOK IRRIGATING CYSTOTOMES
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