Cleared Traditional

K881134 - SLT CONTACT LASER SYSTEM OCULOPLASTICS

K881134 is an FDA 510(k) clearance for SLT CONTACT LASER SYSTEM OCULOPLASTICS, manufactured by Surgical Laser Technologies, Inc.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K881134 · Surgical Laser Technologies, Inc. · Ophthalmic device
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Jun 1988
Decision
82d
Days
Class 2
Risk

K881134 is an FDA 510(k) clearance for the SLT CONTACT LASER SYSTEM OCULOPLASTICS. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Surgical Laser Technologies, Inc. (Malvern, US). The FDA issued a Cleared decision on June 6, 1988 after a review of 82 days - a notably fast clearance cycle.

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: 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 Surgical Laser Technologies, Inc. devices

FDA 510(k) Submission Details - K881134

510(k) Number K881134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1988
Decision Date June 06, 1988
Days to Decision 82 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
28d faster than avg
Panel avg: 110d · This submission: 82d
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 89
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K881134.
SLT CL60 CONTACT LASER SYSTEM, CUTTING & COAGULA.
K882908 · Surgical Laser Technologies, Inc. · Sep 1988
NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)
K883213 · Nidek, Inc. · Sep 1988
RESUBMITTED DIODE LASER COAGULATOR
K882372 · CooperVision, Inc. · Aug 1988
PRISMA DISPOSABLE ENDO-OCULAR PROBE
K875000 · Advanced Surgical Products, Inc. · Apr 1988
ZEISS VISULAS ARGON LASER
K874609 · Carl Zeiss, Inc. · Jan 1988
NIDEK ADC-8000 LASER SYSTEM
K872846 · Nidek, Inc. · Oct 1987