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)
Top companies in GEX
| Company | 510(k)s | Recalls |
|---|---|---|
| Cynosure, Inc. | 84 | 1 |
| Lumenis | 60 | 11 |
| Sharplan Lasers, Inc. | 66 | 0 |
| Quanta System Spa | 57 | 6 |
| Candela Corp. | 53 | 5 |
| Laserscope | 49 | 0 |
| Trimedyne, Inc. | 48 | 0 |
| Heraeus Lasersonics, Inc. | 37 | 0 |
| Surgical Laser Technologies, Inc. | 35 | 0 |
| Boston Scientific | 11 | 23 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2026 | Lutronic 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 |
GEX | K203788 |
| Jun 24, 2026 | IPG Medical Corporation Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser. Open, Classified |
GEX | K232568 |
| Mar 30, 2026 | Olympus 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 |
GEX | K242191 |
| Mar 30, 2026 | Olympus 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 |
GEX | K242191 |
| Mar 12, 2026 | Lutronic Corporation CLARITY II Laser System; Model No. 1110200210. Open, Classified |
GEX | K183566 |
| Jan 16, 2026 | LEASEIR 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 |
GEX | K214049 |
| Aug 21, 2025 | LUMENIS, 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 |
GEX | K130164 |
| Jun 6, 2025 | Olympus 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 |
GEX | K242191 |
| Jun 6, 2025 | Olympus 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 |
GEX | K242191 |
| Jun 6, 2025 | Olympus 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 |
GEX | K242191 |
| Jun 6, 2025 | Olympus 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 |
GEX | K242191 |
| May 1, 2025 | Olympus 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 |
GEX | K242191 |
| Mar 5, 2025 | LUMENIS, 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 |
GEX | K170121 |
| Dec 5, 2024 | WINGDERM ELECTRO-OPTICS LTD. Diode Laser Hair Removal model: WLA-01 Open, Classified |
GEX | K191611 |
| Oct 18, 2024 | Olympus 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 |
GEX | K221306 |
| Oct 18, 2024 | Olympus 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 |
GEX | K221306 |
| Aug 5, 2024 | Olympus Corporation of the Americas Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL Open, Classified |
GEX | K221306 |
| Aug 5, 2024 | Olympus Corporation of the Americas Soltive Pro SuperPulsed Laser System, Model TFL-SLS Open, Classified |
GEX | K221306 |
| Aug 5, 2024 | Olympus Corporation of the Americas Soltive Premium SuperPulsed Laser System, Model TFL-PLS Open, Classified |
GEX | K221306 |
| May 13, 2024 | Karl Storz Endoscopy LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000 Open, Classified |
GEX | K942786 |
| Mar 27, 2024 | Olympus Corporation of the Americas SOLTIVE Premium SuperPulsed Laser (TFL-PLS ) Open, Classified |
GEX | K221306 |
| Mar 27, 2024 | Olympus Corporation of the Americas SOLTIVE Pro SuperPulsed Laser (TFL-SLS ) Open, Classified |
GEX | K221306 |
| Jan 20, 2024 | Accure Acne, Inc Accure Laser System, Model: PFMS00004 Open, Classified |
GEX | K222109 |
| Jan 18, 2024 | Olympus 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 |
GEX | K183647 |
| Jan 12, 2024 | Olympus Corporation of the Americas SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS Open, Classified |
GEX | K221306 |
| Jan 12, 2024 | Olympus Corporation of the Americas Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC Open, Classified |
GEX | K183647 |
| Jan 12, 2024 | Olympus 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 |
GEX | K183647 |
| Oct 13, 2023 | Advance-Esthetic LLC MED-810A Zemits NDPrime Laser products Open, Classified |
GEX | None listed |
| Jul 21, 2023 | Boston 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 |
GEX | K210925 |
| Jul 21, 2023 | Boston 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 |
GEX | K210925 |
| Jul 21, 2023 | Boston 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 |
GEX | K210925 |
| Jul 21, 2023 | Boston 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 |
GEX | K210925 |
| Jul 21, 2023 | Boston 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 |
GEX | K210925 |
| Jul 21, 2023 | Boston 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 |
GEX | K210925 |
| Jul 21, 2023 | Boston 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 |
GEX | K210925 |
| Sep 27, 2022 | Angiodynamics, 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 |
GEX | K041957 |
| May 31, 2022 | Boston Scientific Corporation GreenLight HPSEA Laser Fibers, UPN 0010-2092 Open, Classified |
GEX | K062719 |
| May 26, 2022 | Olympus 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 |
GEX | K183647 |
| Jul 27, 2021 | Clarus Medical, Llc Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002 Terminated |
GEX | K040424 K922881 |
| Jun 30, 2021 | Olympus 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 |
GEX | K211401 |
| Apr 27, 2021 | Quanta System, S.p.A. Quanta System Sterile Optical Laser Fiber, reusable Terminated |
GEX | K160513 |
| Apr 27, 2021 | Quanta System, S.p.A. Quanta System Sterile Optical Laser Fiber, single use Terminated |
GEX | K131473 |
| Apr 27, 2021 | Quanta System, S.p.A. Olympus Sterile Optical Laser Fiber, single use and reusable Terminated |
GEX | K180158 |
| Apr 1, 2021 | CLINICAL 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 |
GEX | K151569 K163103 |
| Jun 8, 2020 | Medtronic 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 |
GEX | K181864 |
| Apr 1, 2020 | Ra 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 |
GEX | K062963 |
| Mar 30, 2020 | Boston 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 |
GEX | K120870 |
| Jan 29, 2020 | Inova Lasers LLC Class IV New Era medical laser device Open, Classified |
GEX | K182604 |
| Oct 24, 2019 | Candela Corporation Canister HFC-134a /980g, ALUM, 15 pack
Product Number: 1600-00-0224
Revision .0C
Coolant canister for use with surgical laser. Terminated |
GEX | None listed |
| Oct 24, 2019 | Candela Corporation Canister HFC-134a / 980g, ALUM
Product Number: 1600-00-0223
Revision .0C
Coolant canister for use with surgical laser. Terminated |
GEX | None listed |
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