Cleared Traditional

K861845 - MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-...

K861845 is an FDA 510(k) clearance for MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-..., manufactured by Directed Energy, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHR cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K861845 · Directed Energy, Inc. · Obstetrics & Gynecology device
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Aug 1986
Decision
90d
Days
Class 2
Risk

K861845 is an FDA 510(k) clearance for the MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE. Classified as Laser, Surgical, Gynecologic (product code HHR), Class II - Special Controls.

Submitted by Directed Energy, Inc. (Los Angeles, US). The FDA issued a Cleared decision on August 11, 1986 after a review of 90 days - within the typical 510(k) review window.

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 Directed Energy, Inc. devices

FDA 510(k) Submission Details - K861845

510(k) Number K861845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1986
Decision Date August 11, 1986
Days to Decision 90 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
70d faster than avg
Panel avg: 160d · This submission: 90d
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 19
Devices cleared under the same product code (HHR) and FDA review panel - the closest regulatory comparables to K861845.
SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE
K862861 · Directed Energy, Inc. · Oct 1986
CABOT LASER LAPAROSCOPY ACCESSORY SET
K862228 · Cabot Medical Corp. · Aug 1986
ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION
K862456 · Cooper Lasersonics, Inc. · Aug 1986
ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY
K853876 · Endo Lase, Inc. · Feb 1986
ENDO-LASE CD40 CO2 FOR GYNECOLOGY
K853903 · Endo Lase, Inc. · Feb 1986
MEDILAS 2 ND:YAG LASER SURGERY SYSTEM
K855093 · Endo Lase, Inc. · Feb 1986