Cleared Traditional

K233756 - Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) (FDA 510(k) Clearance)

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

K233756 · Rhein Laser Technologies Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
70d
Days
Class 2
Risk

K233756 is an FDA 510(k) clearance for the Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755). 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 Rhein Laser Technologies Co., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on February 2, 2024 after a review of 70 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 Rhein Laser Technologies Co., Ltd. devices

Submission Details

510(k) Number K233756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2023
Decision Date February 02, 2024
Days to Decision 70 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 114d · This submission: 70d
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 K233756.
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