Cleared Traditional

K971950 - INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER

K971950 is an FDA 510(k) clearance for INFINITECH MULTI-SPOT SLIT LAMP LASER A..., manufactured by Infinitech, Inc.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K971950 · Infinitech, Inc. · Ophthalmic device
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Aug 1997
Decision
65d
Days
Class 2
Risk

K971950 is an FDA 510(k) clearance for the INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Infinitech, Inc. (Chesterfield, US). The FDA issued a Cleared decision on August 1, 1997 after a review of 65 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 Infinitech, Inc. devices

FDA 510(k) Submission Details - K971950

510(k) Number K971950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1997
Decision Date August 01, 1997
Days to Decision 65 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 110d · This submission: 65d
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 118
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K971950.
LUXSCOPE
K973193 · Luxtec Corp. · Nov 1997
RODENSTOCK LASER SLITLAMP
K973220 · G. Rodenstock Instrumente GmbH · Nov 1997
LASEREX LP1532 PHOTOCOAGULATOR
K972514 · Ellex Medical Pty, Ltd. · Oct 1997
CERALAS DIODE LASER SYSTEM (CERALAS D2)
K964751 · Ceram Optec, Inc. · Feb 1997
OCULIGHT GL
K960971 · Iriderm Div. · Aug 1996
DIOPEXY PROBE
K960522 · Iriderm Div. · Jul 1996