Cleared Traditional

K881952 - SHARPLAN MODELS 719-O COLPOSLAD CO2 SU MICROMANI. (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K881952 · Sharplan Lasers, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1988
Decision
24d
Days
Class 2
Risk

K881952 is an FDA 510(k) clearance for the SHARPLAN MODELS 719-O COLPOSLAD CO2 SU MICROMANI.. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Sharplan Lasers, Inc. (Allendale, US). The FDA issued a Cleared decision on June 3, 1988 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery 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 Sharplan Lasers, Inc. devices

Submission Details

510(k) Number K881952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1988
Decision Date June 03, 1988
Days to Decision 24 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 114d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEX Powered Laser Surgical Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEX Powered Laser Surgical Instrument

All 2855
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K881952.
YellowStar
K261094 · Asclepion Laser Technologies GmbH · Apr 2026
VANISH PRO
K253765 · Ddc Technologies, Inc. · Apr 2026
Q-Switched Nd: YAG Laser System (Glamor Q)
K260153 · Nanjing Bestview Laser S&T Co., Ltd. · Apr 2026
Diode Laser Therapy Systems (V19)
K260307 · Weifang Mingliang Electronics Co., Ltd. · Apr 2026
Picosecond Nd:YAG Laser Systems (Model: HS-298)
K260017 · Shanghai Apolo Medical Technology Co., Ltd. · Apr 2026
CO2 Laser System
K260257 · Sanhe Meditech Co., Ltd. · Mar 2026