Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 15, 2022 Lumenis Be, Inc. Shlomit Segman Sr. Director, Regulatory Affairs 1870 South Milestone Drive Salt Lake City, UT 84104 Re: K220877 Trade/Device Name: Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HOF Dated: March 14, 2022 Received: March 25, 2022 Dear Shlomit Segman: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. 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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531- Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Anjana Jain, PhD Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K220877 Device Name Selecta Duet LED, Digital Duet, Selecta LED Trio, and Digital Trio Laser Systems Indications for Use (Describe) · Selecta Duet LED or Digital Duet: Photodisruption of ocular tissue using light energy emitted by a Nd: Y AG laser, including discission of the posterior capsule of the eye (posterior capsulotomy) iridectorny, and selective laser trabeculoplasty. · Selecta LED Trio or Digital Trio: Photodisruption of ocular tissue using light energy emitted by a Nd: Y AG laser, including discission of the posterior capsule of the eye (posterior capsulotomy) iridectorny, selective laser trabeculoplasty, and retinal photocoagulation. | Type of Use (Select one or both, as applicable) | |-----------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size:10pt"> <span style="font-family:Wingdings">þ</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | | <span style="font-size:10pt"> <span style="font-family:Wingdings">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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K220877 # 510(k) SUMMARY | PREPARATION DATE: | July 14, 2022 | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | APPLICANT: | Lumenis Be, Inc.<br>1870 South Milestone Drive<br>Salt Lake City, Utah 84104 | | CONTACT PERSON: | Shlomit Segman, PhD<br>Sr. Director, Regulatory Affairs<br>Lumenis Be Ltd.<br>Tel: +972-4-9599230 or +972-52-3667233 | | DEVICE TRADE NAME: | Selecta Duet LED Laser System<br>Digital Duet Laser System<br>Selecta LED Trio Laser System<br>Digital Trio Laser System | | CLASSIFICATION NAME: | Powered Laser Surgical Instrument | | DEVICE CLASSIFICATION: | Class II (21CFR§886.4390) | | PRODUCT CODE: | HQF | | PREDICATE DEVICE: | Selecta Duet and Trio Laser Systems<br>Applicant: Lumenis, Inc.<br>510(k) Number: K081704<br>Classification Name: Powered Laser Surgical Instrument<br>Device Classification: Class II (21CFR§878.4810)<br>Product Code: GEX, HQF | The Selecta Duet and Trio Laser Systems have not been subject to a design related recall.### DEVICE DESCRIPTION: The Selecta Duet LED and Digital Duet subject devices are each a fully integrated, highperformance diagnostic slit lamp and therapeutic laser delivery system. The diagnostic slit lamp is for examining the anterior segment of the eye, from the corneal epithelium to the posterior capsule. The integrated Nd:YAG Q-Switch laser module provides short pulses at the wavelength corresponding with the selected operating mode. Two modes are available: {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Lumenis logo. The logo consists of a blue circle with a white "U" shape inside, followed by the word "Lumenis" in blue. Below the word "Lumenis" is the phrase "Energy to Healthcare" in a smaller font, also in blue. - PD (YAG) mode: 1064 nm for photodisruption (PD) of ocular tissues in procedures such ● as posterior capsulotomy, iridotomy, and iridectomy, and - SLT mode: 532 nm for Selective Laser Trabeculoplasty (SLT). ● The Selecta LED Trio and Digital Trio subject devices are each created by connecting the Selecta LED Duet and Digital Duet, respectively, to a compatible, FDA-cleared, Lumenis continuous 532 nm wavelength photocoagulator laser, via the LaserLink S. When the user connects the Duet to the LaserLink S, the Duet-part acts only as a Slit Lamp since the integrated Duet-laser is disabled and the laser in the external photocoagulator takes over. This combination adds the ability to perform retinal photocoagulation, as well as other indications cleared for the continuous 532 nm wavelength photocoagulator laser. The user disconnects the Duet from the LaserLink S for the system to perform as a Duet. ### INTENDED USE/INDICATIONS FOR USE: - · Selecta Duet LED or Digital Duet: Photodisruption of ocular tissue using light energy emitted by a Nd:YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), iridotomy/ iridectomy, and selective laser trabeculoplasty. - · Selecta LED Trio or Digital Trio: Photodisruption of ocular tissue using light energy emitted by a Nd: Y AG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), iridotomy/ iridectomy, selective laser trabeculoplasty, and retinal photocoagulation. ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: The subject laser systems are substantially equivalent to their respective predicate, predecessor K081704 laser systems. This is a catch-up 510(k) submission intended to update the Selecta Family of Laser Systems record at FDA with the changes that have been implemented in the subject devices. As such, the intended use/indications remain substantial equivalent to that for the cleared devices. Further, the implemented changes were primarily to be responsive to user feedback, upgrade to the latest user interface, or reflect a need to change a supplier or manufacturing contractor. The key changes are captured in the comparison table below. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the Lumenis logo. The logo consists of a blue circle with a white "L" inside, followed by the word "Lumenis" in blue. Below the word "Lumenis" is the phrase "Energy to Healthcare". # Table: Comparison of Technological Characteristics | | Cleared Devices | Subject Devices: | | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | Selecta Duet and Trio Laser<br>Systems (K081704) | Selecta Duet LED, Digital Duet,<br>LED Trio, and Digital Trio Laser<br>Systems | | | | GENERAL | | | | Manufacturer | Lumenis, Inc. | Lumenis Be, Inc. | | | Regulation<br>Number | 21CFR§878.4810 | Same | | | Regulation<br>Name | Powered Laser Surgical Instrument | Same | | | Procodes | GEX and HQF | Same | | | Indications<br>for Use | • Selecta Duet: Photodisruption of<br>ocular tissue using light energy<br>emitted by a Nd:YAG laser,<br>including discission of the posterior<br>capsule of the eye (posterior<br>capsulotomy), and discission of<br>pupillary membranes (pupillary<br>membranectomy) in aphakic and<br>pseudophakic patients, and<br>iridotomy/iridectomy and selective<br>laser trabeculoplasty.<br>• Selecta Trio: Photodisruption of<br>ocular tissue using light energy<br>emitted by a Nd:YAG laser,<br>including discission of the posterior<br>capsule of the eye (posterior<br>capsulotomy), and discission of<br>pupillary membranes (pupillary<br>membranectomy) in aphakic and<br>pseudophakic patients, and<br>iridotomy/iridectomy, retinal<br>photocoagulation and selective<br>laser trabeculoplasty. | • Selecta Duet LED or Digital<br>Duet: Photodisruption of ocular<br>tissue using light energy emitted<br>by a Nd:YAG laser, including<br>discission of the posterior capsule<br>of the eye (posterior<br>capsulotomy), iridotomy/<br>iridectomy, and selective laser<br>trabeculoplasty.<br>• Selecta LED Trio or Digital<br>Trio: Photodisruption of ocular<br>tissue using light energy emitted<br>by a Nd:YAG laser, including<br>discission of the posterior capsule<br>of the eye (posterior<br>capsulotomy), iridotomy/<br>iridectomy, retinal<br>photocoagulation, and selective<br>laser trabeculoplasty. | | | LASER SPECIFICATIONS | | | | | Type | Frequency-doubled/Q-switched<br>Nd:YAG | Identical | | | | Cleared Devices | Subject Devices: | | | | Selecta Duet and Trio Laser<br>Systems (K081704) | Selecta Duet LED, Digital Duet,<br>LED Trio, and Digital Trio Laser<br>Systems | | | Principal<br>output -<br>wavelength | 532 and 1064 nm | Identical | | | Operating<br>mode | Frequency doubled/Fundamental,<br>pulsed | Identical | | | Pulse<br>duration | 3 nanoseconds | Identical | | | Energy (mJ) | For 532 nm laser: 2 maximum<br>For 1064 nm laser: 30 maximum | Identical | | | Laser beam<br>spot size | For 532 nm laser:<br>400 um at visual focal plane<br>For 1064 nm laser:<br><8 um full width half maximum | For 532 nm laser:<br>400 um at visual focal plane<br>For 1064 nm laser:<br><11 µm at visual focal plane, 8 µm<br>full width half maximum calculated | | | CDRH Rad.<br>Health<br>classification | Class IIIb Lasers | Identical | | | IEC 60825<br>classification | Class 3B | Identical | | | Laser<br>Actuation | Button or footswitch | Joystick button or Footswitch | | | | AIMING BEAM SPECIFICATIONS | | | | Type | CW Diode laser | Identical | | | Principal<br>output | 635 nm wavelength | Identical | | | CDRH Rad.<br>Health<br>classification | Class II | Identical | | | IEC 60825<br>classification | Class 2 | Identical | | | | SLIT LAMP | | | | Field of view | 11.3 mm diameter at 16X<br>magnification | Identical | | | Working<br>distance | 70 mm | Identical | | | | Cleared Devices<br>Selecta Duet and Trio Laser<br>Systems (K081704) | Subject Devices:<br>Selecta Duet LED, Digital Duet,<br>LED Trio, and Digital Trio Laser<br>Systems | | | Slit rotation<br>(°) | -90 (horizontal) to + 90 (horizontal) | Identical | | | Bulb | Halogen, 30 W | Light Emitting Diodes, 5W | | | COMPATIBLE 532 nm PHOTOCOAGULATOR LASER | | | | | | • Novus Spectra Laser System | • Smart532 (K151109) | | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Lumenis. The logo consists of a blue circle with a white "L" inside, followed by the word "Lumenis" in blue. Below the word "Lumenis" is the tagline "Energy to Healthcare". {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the Lumenis logo. The logo consists of a blue circle with a white "L" inside, followed by the word "Lumenis" in blue. Below the word "Lumenis" is the phrase "Energy to Healthcare" in a smaller font. The differences between the subject devices and their respective, predecessor, predicated devices do not raise different questions of safety and effectiveness and have been confirmed through testing. # PERFORMANCE TESTING: Performance testing demonstrates that the subject devices are as safe and as effective as their respective, predicate, predecessor devices. These tests included: - . Evaluating the implemented changes using the same recognized standards that were used for the cleared devices: | Standard Number | Standard Name | |---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ANSI/AAMI ES60601-<br>1:2005/ A2:2010 | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential performance<br>(IEC 60601-1:2005, MOD) | | IEC 60601-1-2 Edition<br>4.0:2014 | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential performance -<br>Collateral Standard: Electromagnetic disturbances -<br>Requirements and tests | | IEC 60601-2-22 Ed. 3.1<br>b:2012 | Medical electrical equipment - Part 2-22: Particular<br>requirements for basic safety and essential performance<br>of surgical, cosmetic, therapeutic and diagnostic laser<br>equipment | | IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification<br>and requirements | | ISO 15004-2 | Ophthalmic instruments — Fundamental requirements<br>and test methods — Part 2: Light hazard protection | | ISO 14971 Third Edition<br>2019-12 | Medical devices - Application of risk management to<br>medical devices | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Lumenis, a company that specializes in energy to healthcare. The logo features a stylized letter "U" inside of a circle, followed by the company name "Lumenis" in a sans-serif font. Below the company name is the tagline "Energy to Healthcare" in a smaller font. The logo is clean and modern, with a focus on simplicity and clarity. - Software/Bench Testing ● Lumenis developed and verified the software in accordance with a major level of concern described in the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and also per the IEC 62304:2006 and A1:2015 Medical Device Software - Software Life Cycle Processes standard. The software/bench tests conducted on the modifications confirmed that they met their requirements. ### CONCLUSIONS: The provided performance testing supports a substantial equivalence determination. The subject devices are substantially equivalent to their respective, predicate, predecessor devices.