Cleared Traditional

K852208 - PHACO-BAC STOP FILTER KIT

K852208 is the FDA 510(k) clearance for PHACO-BAC STOP FILTER KIT by Staar Surgical Co.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K852208 · Staar Surgical Co. · Ophthalmic device
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Aug 1985
Decision
91d
Days
Class 2
Risk

K852208 is an FDA 510(k) clearance for the PHACO-BAC STOP FILTER KIT. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on August 20, 1985 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Staar Surgical Co. devices

Submission Details

510(k) Number K852208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1985
Decision Date August 20, 1985
Days to Decision 91 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 110d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
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 - HQC Unit, Phacofragmentation

All 88
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K852208.
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