Cleared Traditional

K801877 - SLIT LAMP ATTACHMENT

K801877 is the FDA 510(k) clearance for SLIT LAMP ATTACHMENT by Cavitron Corp.. It is a Class 2 Ophthalmic device (product code HQB) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K801877 · Cavitron Corp. · Ophthalmic device
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Sep 1980
Decision
41d
Days
Class 2
Risk

K801877 is an FDA 510(k) clearance for the SLIT LAMP ATTACHMENT. Classified as Photocoagulator And Accessories (product code HQB), Class II - Special Controls.

Submitted by Cavitron Corp. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4690 - 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 Cavitron Corp. devices

Submission Details

510(k) Number K801877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1980
Decision Date September 16, 1980
Days to Decision 41 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 110d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQB Photocoagulator And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HQB Photocoagulator And Accessories

All 9
Devices cleared under the same product code (HQB) and FDA review panel - the closest regulatory comparables to K801877.
NIDEK AC-2000 LASER SYSTEM
K860011 · Nidek, Inc. · Feb 1986
ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS
K844197 · Nidek, Inc. · Dec 1984
ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE
K844198 · Nidek, Inc. · Dec 1984
LAMP DELIVERY SYS.-PHOTOCOAGULATION
K772213 · Varian Assoc., Inc. · Dec 1977
PHOTOCOAGULATOR, LOG 3 PORTABLE XENON
K760444 · Varian Assoc., Inc. · Aug 1976