Cleared Traditional

K870902 - LOOK RETROBULBAR NEEDLES

K870902 is an FDA 510(k) clearance for LOOK RETROBULBAR NEEDLES, manufactured by Look, Inc.. The device is a Class 1 Ophthalmic device with product code HMX cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K870902 · Look, Inc. · Ophthalmic device
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Mar 1987
Decision
15d
Days
Class 1
Risk

K870902 is an FDA 510(k) clearance for the LOOK RETROBULBAR NEEDLES. Classified as Cannula, Ophthalmic (product code HMX), Class I - General Controls.

Submitted by Look, Inc. (Boston, US). The FDA issued a Cleared decision on March 20, 1987 after a review of 15 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 Look, Inc. devices

FDA 510(k) Submission Details - K870902

510(k) Number K870902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1987
Decision Date March 20, 1987
Days to Decision 15 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
95d faster than avg
Panel avg: 110d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

HMX Device Classification - Class 1, General Controls

Product Code HMX Cannula, Ophthalmic
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 - HMX Cannula, Ophthalmic

All 48
Devices cleared under the same product code (HMX) and FDA review panel - the closest regulatory comparables to K870902.
LOOK IRRIGATING/ASPIRATING CANNULA W/TEFLON SHEATH
K872884 · Look, Inc. · Aug 1987
MVS 2.5MM, 4.0MM, 6.0MM INFUSION CANNULA
K871605 · Advanced Surgical Products, Inc. · Jun 1987
OPHTHALMIC CANNULA
K872151 · Pharmacia, Inc. · Jun 1987
LOOK IRRIGATING/ASPIRATING CANNULAS
K870436 · Look, Inc. · Feb 1987
LOOK IRRIGATING CANNULAS
K870438 · Look, Inc. · Feb 1987
LOOK CORTEX EXTRACTORS
K870441 · Look, Inc. · Feb 1987