Cleared Traditional

K885255 - MDL-1 LASERTRIPTER(TM)

K885255 is the FDA 510(k) clearance for MDL-1 LASERTRIPTER(TM) by Candela Laser Corp.. It is a Class 2 Gastroenterology & Urology device (product code FFK) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K885255 · Candela Laser Corp. · Gastroenterology & Urology device
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Jun 1989
Decision
160d
Days
Class 2
Risk

K885255 is an FDA 510(k) clearance for the MDL-1 LASERTRIPTER(TM). Classified as Lithotriptor, Electro-hydraulic (product code FFK), Class II - Special Controls.

Submitted by Candela Laser Corp. (Wayland, US). The FDA issued a Cleared decision on June 1, 1989 after a review of 160 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4480 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Candela Laser Corp. devices

Submission Details

510(k) Number K885255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1988
Decision Date June 01, 1989
Days to Decision 160 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 130d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FFK Lithotriptor, Electro-hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4480
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FFK Lithotriptor, Electro-hydraulic

All 29
Devices cleared under the same product code (FFK) and FDA review panel - the closest regulatory comparables to K885255.
9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
K914516 · Northgate Technologies, Inc. · Jan 1992
1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
K914514 · Northgate Technologies, Inc. · Jan 1992
1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
K913955 · Northgate Technologies, Inc. · Nov 1991
MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS
K883189 · KARL STORZ Endoscopy-America, Inc. · Feb 1989
MDL-1 LASERTRIPTER
K880503 · Candela Laser Corp. · Jun 1988
CANDELA MODEL MDL-1 LASER LITHOTRIPTOR
K863642 · Candela Corp. · Dec 1986