Cleared Traditional

K875000 - PRISMA DISPOSABLE ENDO-OCULAR PROBE

K875000 is an FDA 510(k) clearance for PRISMA DISPOSABLE ENDO-OCULAR PROBE, manufactured by Advanced Surgical Products, Inc.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K875000 · Advanced Surgical Products, Inc. · Ophthalmic device
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Apr 1988
Decision
131d
Days
Class 2
Risk

K875000 is an FDA 510(k) clearance for the PRISMA DISPOSABLE ENDO-OCULAR PROBE. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Advanced Surgical Products, Inc. (Chesterfield, US). The FDA issued a Cleared decision on April 13, 1988 after a review of 131 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 Advanced Surgical Products, Inc. devices

FDA 510(k) Submission Details - K875000

510(k) Number K875000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1987
Decision Date April 13, 1988
Days to Decision 131 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
21d slower than avg
Panel avg: 110d · This submission: 131d
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 139
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K875000.
NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)
K883213 · Nidek, Inc. · Sep 1988
RESUBMITTED DIODE LASER COAGULATOR
K882372 · CooperVision, Inc. · Aug 1988
SLT CONTACT LASER SYSTEM OCULOPLASTICS
K881134 · Surgical Laser Technologies, Inc. · Jun 1988
ZEISS VISULAS ARGON LASER
K874609 · Carl Zeiss, Inc. · Jan 1988
NIDEK ADC-8000 LASER SYSTEM
K872846 · Nidek, Inc. · Oct 1987
MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC
K870839 · Directed Energy, Inc. · May 1987