Cleared Traditional

K243121 - SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA (FDA 510(k) Clearance)

Also includes:
TCRH 7-SMA FEF 2.2-SMA CFE 0.6-SMA SSRH 8Z-SMA SSRH 4-SMA SSRH 6-SMA SSRH 9-SMA SSRH 10-SMA SSRH 11-SMA SSRH 7L-SMA TCRH 7Z-SMA FEF 1.8-SMA CFE 0.55-SMA CFE 0.36-SMA LAL 550-SMA LAL 550Z-SMA LAL 365-SMA LAL 365Z-SMA ER2 ERP2 GR2 GRP2 ER4 ERP4 GR4 GRP4 ER6 ERP6 GR6 GRP6 ER8 ERP8 GR8 GRP8 ER10 ERP10 GR10 GRP10 ER12 ERP12 GR12 GRP12 MD2.5 MD3.5 HP1.0 MTP1.5 MTP3.5 MTRG1.5

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

K243121 · Jiangxi Medex Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
83d
Days
Class 2
Risk

K243121 is an FDA 510(k) clearance for the SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA. 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 Jiangxi Medex Technology Co., Ltd. (Jiangxi, CN). The FDA issued a Cleared decision on December 22, 2024 after a review of 83 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 Jiangxi Medex Technology Co., Ltd. devices

Submission Details

510(k) Number K243121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date December 22, 2024
Days to Decision 83 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 114d · This submission: 83d
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 Consultant

Microkn Medical Technology Service (Shanghai) Co., Ltd.
Owen He

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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