Cleared Traditional

K881459 - NANOLAS ND:YAG OPHTHALMIC LASER (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K881459 · Biophysic Medical, Inc. · Ophthalmic device
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Apr 1988
Decision
7d
Days
Class 3
Risk

K881459 is an FDA 510(k) clearance for the NANOLAS ND:YAG OPHTHALMIC LASER. Classified as Laser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary (product code LOI), Class III - Premarket Approval.

Submitted by Biophysic Medical, Inc. (Pleasant Hill, US). The FDA issued a Cleared decision on April 13, 1988 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. 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 Biophysic Medical, Inc. devices

Submission Details

510(k) Number K881459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1988
Decision Date April 13, 1988
Days to Decision 7 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 110d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOI Laser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.