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Panels › General, Plastic Surgery › Product code GEX · Class 2

Powered Laser Surgical Instrument

Regulation 878.4810

73510(k)s in 12 months (2,892 all time)
6recalls in 12 months (201 all time)
150recalls that name a 510(k)
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Top companies in GEX

DateFirm and productCodeLinked 510(k)
Sep 4, 2026Lutronic Corporation
Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of 532 nm and 1064 nm through a fiber-optic handpiece. The system
Open, Classified
GEXK203788
Jun 24, 2026IPG Medical Corporation
Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Open, Classified
GEXK232568
Mar 30, 2026Olympus Corporation of the Americas
Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An electricity powered de
Open, Classified
GEXK242191
Mar 30, 2026Olympus Corporation of the Americas
Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity po
Open, Classified
GEXK242191
Mar 12, 2026Lutronic Corporation
CLARITY II Laser System; Model No. 1110200210.
Open, Classified
GEXK183566
Jan 16, 2026LEASEIR TECHNOLOGIES SLU
Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leaseir MHR Xcell is a surgical laser instrument for use in gener
Completed
GEXK214049
Aug 21, 2025LUMENIS, LTD.
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
Open, Classified
GEXK130164
Jun 6, 2025Olympus Corporation of the Americas
Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL-FBX940R-JA (Japan O
Open, Classified
GEXK242191
Jun 6, 2025Olympus Corporation of the Americas
Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-
Open, Classified
GEXK242191
Jun 6, 2025Olympus Corporation of the Americas
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only); Software Version: N/A Product Description:
Open, Classified
GEXK242191
Jun 6, 2025Olympus Corporation of the Americas
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); Product Description: SOLTIVE Laser Systems use
Open, Classified
GEXK242191
May 1, 2025Olympus Corporation of the Americas
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology to in
Open, Classified
GEXK242191
Mar 5, 2025LUMENIS, LTD.
(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.
Open, Classified
GEXK170121
Dec 5, 2024WINGDERM ELECTRO-OPTICS LTD.
Diode Laser Hair Removal model: WLA-01
Open, Classified
GEXK191611
Oct 18, 2024Olympus Corporation of the Americas
Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS
Open, Classified
GEXK221306
Oct 18, 2024Olympus Corporation of the Americas
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS
Open, Classified
GEXK221306
Aug 5, 2024Olympus Corporation of the Americas
Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL
Open, Classified
GEXK221306
Aug 5, 2024Olympus Corporation of the Americas
Soltive Pro SuperPulsed Laser System, Model TFL-SLS
Open, Classified
GEXK221306
Aug 5, 2024Olympus Corporation of the Americas
Soltive Premium SuperPulsed Laser System, Model TFL-PLS
Open, Classified
GEXK221306
May 13, 2024Karl Storz Endoscopy
LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
Open, Classified
GEXK942786
Mar 27, 2024Olympus Corporation of the Americas
SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
Open, Classified
GEXK221306
Mar 27, 2024Olympus Corporation of the Americas
SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
Open, Classified
GEXK221306
Jan 20, 2024Accure Acne, Inc
Accure Laser System, Model: PFMS00004
Open, Classified
GEXK222109
Jan 18, 2024Olympus Corporation of the Americas
SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS
Open, Classified
GEXK183647
Jan 12, 2024Olympus Corporation of the Americas
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Open, Classified
GEXK221306
Jan 12, 2024Olympus Corporation of the Americas
Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
Open, Classified
GEXK183647
Jan 12, 2024Olympus Corporation of the Americas
Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
Open, Classified
GEXK183647
Oct 13, 2023Advance-Esthetic LLC
MED-810A Zemits NDPrime Laser products
Open, Classified
GEXNone listed
Jul 21, 2023Boston Scientific Corporation
Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy 5-pack UPN: M006L8406961
Open, Classified
GEXK210925
Jul 21, 2023Boston Scientific Corporation
Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Single-pack UPN): M006L8406960
Open, Classified
GEXK210925
Jul 21, 2023Boston Scientific Corporation
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Box of 5)UPN: M006L8406911
Open, Classified
GEXK210925
Jul 21, 2023Boston Scientific Corporation
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN: M006L8406910
Open, Classified
GEXK210925
Jul 21, 2023Boston Scientific Corporation
Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. 5-pack UPN: M006L8405961
Open, Classified
GEXK210925
Jul 21, 2023Boston Scientific Corporation
Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN : M006L8405960
Open, Classified
GEXK210925
Jul 21, 2023Boston Scientific Corporation
Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Single-pack UPN : M006L8405910
Open, Classified
GEXK210925
Sep 27, 2022Angiodynamics, Inc.
VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the treatment of varicose veins.
Open, Classified
GEXK041957
May 31, 2022Boston Scientific Corporation
GreenLight HPSEA Laser Fibers, UPN 0010-2092
Open, Classified
GEXK062719
May 26, 2022Olympus Corporation of the Americas
SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX200S (Pouch) - 200 Micron Single Use Fiber Model # Labeled TFL-FBX2
Terminated
GEXK183647
Jul 27, 2021Clarus Medical, Llc
Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
Terminated
GEXK040424
K922881
Jun 30, 2021Olympus Corporation of the Americas
Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft t
Terminated
GEXK211401
Apr 27, 2021Quanta System, S.p.A.
Quanta System Sterile Optical Laser Fiber, reusable
Terminated
GEXK160513
Apr 27, 2021Quanta System, S.p.A.
Quanta System Sterile Optical Laser Fiber, single use
Terminated
GEXK131473
Apr 27, 2021Quanta System, S.p.A.
Olympus Sterile Optical Laser Fiber, single use and reusable
Terminated
GEXK180158
Apr 1, 2021CLINICAL LASERTHERMIA SYSTEMS AB
Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the Tranberg MR Introducer; a device used to aid the insertion of
Terminated
GEXK151569
K163103
Jun 8, 2020Medtronic Sofamor Danek USA Inc
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 20763000153551 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an a
Terminated
GEXK181864
Apr 1, 2020Ra Medical Systems, Inc.
Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psoriasis, vitiligo, atopic dermatitis, and leukoderma using phototh
Terminated
GEXK062963
Mar 30, 2020Boston Scientific Corporation
MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
Terminated
GEXK120870
Jan 29, 2020Inova Lasers LLC
Class IV New Era medical laser device
Open, Classified
GEXK182604
Oct 24, 2019Candela Corporation
Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant canister for use with surgical laser.
Terminated
GEXNone listed
Oct 24, 2019Candela Corporation
Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with surgical laser.
Terminated
GEXNone listed

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