Cleared Traditional

K940393 - PEREGRINE WIDE ANGLE LIGHT PIPE

K940393 is an FDA 510(k) clearance for PEREGRINE WIDE ANGLE LIGHT PIPE, manufactured by Peregrine Surgical , Ltd.. The device is a Class 2 Ophthalmic device with product code HJM cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K940393 · Peregrine Surgical , Ltd. · Ophthalmic device
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Sep 1994
Decision
219d
Days
Class 2
Risk

K940393 is an FDA 510(k) clearance for the PEREGRINE WIDE ANGLE LIGHT PIPE. Classified as Transilluminator, Ac-powered (product code HJM), Class II - Special Controls.

Submitted by Peregrine Surgical , Ltd. (Doylestown, US). The FDA issued a Cleared decision on September 2, 1994 after a review of 219 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1945 - 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 Peregrine Surgical , Ltd. devices

FDA 510(k) Submission Details - K940393

510(k) Number K940393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1994
Decision Date September 02, 1994
Days to Decision 219 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 110d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HJM Device Classification - Class 2, Special Controls

Product Code HJM Transilluminator, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1945
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 - HJM Transilluminator, Ac-powered

Devices cleared under the same product code (HJM) and FDA review panel - the closest regulatory comparables to K940393.
PEREGRINE DIFFUSION LIGHT PIPE
K950529 · Peregrine Surgical , Ltd. · Jun 1995
HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE
K931072 · Hgm, Inc. · Nov 1994
DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS)
K933445 · Storz Instrument Co. · Sep 1994
FIBEROPTIC ILLUMINATED INSTRUMENTS
K934269 · Visitec Co. · May 1994
VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)
K893170 · Keeler Instruments, Inc. · Jun 1989