Cleared Traditional

K853890 - OPHTHALMIC LASER PHOTOCOAGULATOR

K853890 is an FDA 510(k) clearance for OPHTHALMIC LASER PHOTOCOAGULATOR, manufactured by Mira, Inc.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K853890 · Mira, Inc. · Ophthalmic device
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Nov 1985
Decision
54d
Days
Class 2
Risk

K853890 is an FDA 510(k) clearance for the OPHTHALMIC LASER PHOTOCOAGULATOR. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Mira, Inc. (Waltham, US). The FDA issued a Cleared decision on November 12, 1985 after a review of 54 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 Mira, Inc. devices

FDA 510(k) Submission Details - K853890

510(k) Number K853890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1985
Decision Date November 12, 1985
Days to Decision 54 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
56d faster than avg
Panel avg: 110d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQF Device Classification - Class 2, Special Controls

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 99
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K853890.
MODEL 1000 OPHTHALMIC LASER SYSTEM
K862987 · CooperVision, Inc. · Sep 1986
FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE)
K860358 · Hgm, Inc. · Mar 1986
MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS
K854949 · CooperVision, Inc. · Feb 1986
OPHALMIC LASER PHOTOCOAGULATOR
K854288 · Mira, Inc. · Nov 1985
HESSBURG GLIDE UNTRAOCULAR LENS GUIDES
K852529 · Visitec Co. · Sep 1985
SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR
K844357 · Coherent Medical Group · Jun 1985