Cleared Traditional

K881926 - REUSABLE FIBEROPTIC LIGHTPIPE

K881926 is the FDA 510(k) clearance for REUSABLE FIBEROPTIC LIGHTPIPE by Advanced Surgical Products, Inc.. It is a Class 2 Ophthalmic device (product code HQB) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K881926 · Advanced Surgical Products, Inc. · Ophthalmic device
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Jun 1988
Decision
28d
Days
Class 2
Risk

K881926 is an FDA 510(k) clearance for the REUSABLE FIBEROPTIC LIGHTPIPE. Classified as Photocoagulator And Accessories (product code HQB), Class II - Special Controls.

Submitted by Advanced Surgical Products, Inc. (Chesterfield, US). The FDA issued a Cleared decision on June 6, 1988 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4690 - 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 Advanced Surgical Products, Inc. devices

Submission Details

510(k) Number K881926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1988
Decision Date June 06, 1988
Days to Decision 28 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
82d faster than avg
Panel avg: 110d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQB Photocoagulator And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4690
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 - HQB Photocoagulator And Accessories

All 12
Devices cleared under the same product code (HQB) and FDA review panel - the closest regulatory comparables to K881926.
ZIESS ENDOPROBE
K922735 · Carl Zeiss, Inc. · Jul 1992
SLT CONTACT LASER SYSTEM CYCLOPHOTOCOAGULATION
K882679 · Surgical Laser Technologies, Inc. · Dec 1988
SLT CONTACT LASER SYSTEM ENDOPHOTOCOAGULATION
K882441 · Surgical Laser Technologies, Inc. · Sep 1988
NIDEK AC-2000 LASER SYSTEM
K860011 · Nidek, Inc. · Feb 1986
ARGON/KRYPTON LASER SYSTEM 8500
K844209 · Cooper Lasersonics, Inc. · Feb 1985
ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS
K844197 · Nidek, Inc. · Dec 1984