Cleared Traditional

K872254 - SLT CONTACT ND:YAG LASER FOR INTRA-ABDO...

K872254 is an FDA 510(k) clearance for SLT CONTACT ND:YAG LASER FOR INTRA-ABDO..., manufactured by Surgical Laser Technologies, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHR cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K872254 · Surgical Laser Technologies, Inc. · Obstetrics & Gynecology device
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Dec 1987
Decision
208d
Days
Class 2
Risk

K872254 is an FDA 510(k) clearance for the SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL. Classified as Laser, Surgical, Gynecologic (product code HHR), Class II - Special Controls.

Submitted by Surgical Laser Technologies, Inc. (Malvern, US). The FDA issued a Cleared decision on December 14, 1987 after a review of 208 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4550 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgical Laser Technologies, Inc. devices

FDA 510(k) Submission Details - K872254

510(k) Number K872254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1987
Decision Date December 14, 1987
Days to Decision 208 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 160d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHR Device Classification - Class 2, Special Controls

Product Code HHR Laser, Surgical, Gynecologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4550
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HHR Laser, Surgical, Gynecologic

All 20
Devices cleared under the same product code (HHR) and FDA review panel - the closest regulatory comparables to K872254.
KTP/532 LASER FOR OB-GYN USE
K874837 · Laserscope · Mar 1988
MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN
K870841 · Directed Energy, Inc. · Feb 1988
MODEL 20-C, RL-20A/U, OB-10A/U
K872709 · Directed Energy, Inc. · Feb 1988
MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE
K871579 · Sharplan Lasers, Inc. · Nov 1987
CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA
K872253 · Surgical Laser Technologies, Inc. · Oct 1987
MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI.
K871220 · Cooper Lasersonics, Inc. · Jul 1987