Cleared Traditional

Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B) (K240874) - FDA 510(k) Clearance

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

K240874 · Theralaser Medtech (China) Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
60d
Days
Class 2
Risk

K240874 is an FDA 510(k) clearance for the Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B). 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 Theralaser Medtech (China) Co., Ltd. (Ingxiang High-Tech Industrial Park Chang, CN). The FDA issued a Cleared decision on May 28, 2024 after a review of 60 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 Theralaser Medtech (China) Co., Ltd. devices

Submission Details

510(k) Number K240874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2024
Decision Date May 28, 2024
Days to Decision 60 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
55d faster than avg
Panel avg: 115d · This submission: 60d
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 536
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K240874.
Dermalux Tri-Wave MD MKII (1000021)
K240222 · Aesthetic Technology, Ltd. · Jun 2024
InnoVoyce VYLO
K240159 · Innovoyce · May 2024
Regenalase Laser System
K233344 · Ipg Medical · May 2024
Multi-function Platform Systems (BL-M10)
K240474 · Shanghai Bele Medical Technology Co.,Ltd · May 2024
Diode Laser Hair Removal System (SH-VD910)
K240520 · Beijing Sea Heart International Science and Technologyco.Ltd · May 2024
Picosecond Nd:YAG Laser Systems (BL-C10)
K240386 · Shanghai Bele Medical Technology Co.,Ltd · May 2024