Cleared Traditional

K812219 - MODEL 900S INTRAOCULAR PROBE

K812219 is an FDA 510(k) clearance for MODEL 900S INTRAOCULAR PROBE, manufactured by Lumenis, Inc.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K812219 · Lumenis, Inc. · Ophthalmic device
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Nov 1981
Decision
102d
Days
Class 2
Risk

K812219 is an FDA 510(k) clearance for the MODEL 900S INTRAOCULAR PROBE. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Lumenis, Inc. (Walker, US). The FDA issued a Cleared decision on November 16, 1981 after a review of 102 days - within the typical 510(k) review window.

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: 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 Lumenis, Inc. devices

FDA 510(k) Submission Details - K812219

510(k) Number K812219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1981
Decision Date November 16, 1981
Days to Decision 102 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
8d faster than avg
Panel avg: 110d · This submission: 102d
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.