Cleared Traditional

K952894 - VISULINK 900 ARGON

K952894 is the FDA 510(k) clearance for VISULINK 900 ARGON by Carl Zeiss, Inc.. It is a Class 2 Ophthalmic device (product code HQF) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K952894 · Carl Zeiss, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
52d
Days
Class 2
Risk

K952894 is an FDA 510(k) clearance for the VISULINK 900 ARGON. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Carl Zeiss, Inc. (Thornwood, US). The FDA issued a Cleared decision on August 14, 1995 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - 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 Carl Zeiss, Inc. devices

Submission Details

510(k) Number K952894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1995
Decision Date August 14, 1995
Days to Decision 52 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 110d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQF Laser, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
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 - HQF Laser, Ophthalmic

All 79
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K952894.
DC-3300 LASER DIODE PHOTOCOAGULATOR
K013760 · Nidek, Inc. · Feb 2002
CERALAS DIODE LASER SYSTEM (CERALAS D2)
K964751 · Ceram Optec, Inc. · Feb 1997
NIDEK MODEL GYC-1500 AND GYC-2000
K951079 · Nidek, Inc. · Sep 1995
KEELER MULTILASE 3000
K942180 · Keeler Instruments, Inc. · Nov 1994
MEGABEAM ENDOCULAR PROBE
K935747 · Ceram Optec, Inc. · Apr 1994
NIDEK MODEL AC-2300
K932836 · Nidek, Inc. · Nov 1993