Cleared Traditional

K833528 - CARBON DIOXIDE LASER ML 825

K833528 is an FDA 510(k) clearance for CARBON DIOXIDE LASER ML 825, manufactured by Merrimack Laboratories. The device is a Class 2 Obstetrics & Gynecology device with product code HHR cleared through the Traditional 510(k) pathway after a 515-day FDA review.

K833528 · Merrimack Laboratories · Obstetrics & Gynecology device
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Feb 1985
Decision
515d
Days
Class 2
Risk

K833528 is an FDA 510(k) clearance for the CARBON DIOXIDE LASER ML 825. Classified as Laser, Surgical, Gynecologic (product code HHR), Class II - Special Controls.

Submitted by Merrimack Laboratories (Walker, US). The FDA issued a Cleared decision on February 19, 1985 after a review of 515 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Merrimack Laboratories devices

FDA 510(k) Submission Details - K833528

510(k) Number K833528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1983
Decision Date February 19, 1985
Days to Decision 515 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
355d slower than avg
Panel avg: 160d · This submission: 515d
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 17
Devices cleared under the same product code (HHR) and FDA review panel - the closest regulatory comparables to K833528.
ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION
K862456 · Cooper Lasersonics, Inc. · Aug 1986
MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE
K861845 · Directed Energy, Inc. · Aug 1986
CO2 LASER LAPAROSCOPE SYSTEM
K854361 · Richard Wolf Medical Instruments Corp. · Feb 1986
LASER, CO2 SURGICAL
K782054 · Cavitron Corp. · Jan 1979