K Number

Device Name

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

Manufacturer

Lumenis Be, Inc.

Date Cleared

2022-07-15

(112 days)

Product Code

HQF GEX HOF

Regulation Number

886.4390

Intended Use

· 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.

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: 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K081704

Reference Devices

K151109

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on laser technology and diagnostic slit lamp functionality, with no mention of AI or ML.

Therapeutic

Yes
The device is described as a "therapeutic laser delivery system" and its intended uses include procedures like posterior capsulotomy, iridotomy, selective laser trabeculoplasty, and retinal photocoagulation, all of which are medical treatments.

Diagnostic

Yes

The device description explicitly states: "The Selecta Duet LED and Digital Duet subject devices are each a fully integrated, highperformance diagnostic slit lamp and therapeutic laser delivery system."

SaMD (Software as a Medical Device)

The device description clearly states it is a "fully integrated, high-performance diagnostic slit lamp and therapeutic laser delivery system," indicating it includes significant hardware components (slit lamp, laser module).

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that this device is a therapeutic laser delivery system used for photodisruption of ocular tissue. It directly interacts with and treats the eye using light energy.
Intended Use: The intended uses listed (posterior capsulotomy, iridectomy, selective laser trabeculoplasty, retinal photocoagulation) are all therapeutic procedures performed directly on the patient's eye.
Device Description: The description details a slit lamp for examination and a laser module for treatment. There is no mention of analyzing samples taken from the body.

Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

· 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.

Product codes (comma separated list FDA assigned to the subject device)

HOF

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

ocular tissue, eye

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 ES60601-1:2005/ A2:2010	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2 Edition 4.0:2014	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-2-22 Ed. 3.1 b:2012	Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60825-1:2014	Safety of laser products - Part 1: Equipment classification and requirements
ISO 15004-2	Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light hazard protection
ISO 14971 Third Edition 2019-12	Medical devices - Application of risk management to medical devices

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K081704

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K151109

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)

Not Found

Regulation Number and Section

§ 886.4390 Ophthalmic laser.

(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.

Summary

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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. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

542 of the Act); 21 CFR 1000-1050.

statutes and regulations administered by other Federal agencies. 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

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)

Type of Use (Select one or both, as applicable)
þ Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)

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K220877

510(k) SUMMARY

PREPARATION DATE:	July 14, 2022
APPLICANT:	Lumenis Be, Inc.
1870 South Milestone Drive
Salt Lake City, Utah 84104
CONTACT PERSON:	Shlomit Segman, PhD
Sr. Director, Regulatory Affairs
Lumenis Be Ltd.
Tel: +972-4-9599230 or +972-52-3667233
DEVICE TRADE NAME:	Selecta Duet LED Laser System
Digital Duet Laser System
Selecta LED Trio Laser System
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
Applicant: Lumenis, Inc.
510(k) Number: K081704
Classification Name: Powered Laser Surgical Instrument
Device Classification: Class II (21CFR§878.4810)
Product Code: GEX, HQF

The Selecta Duet and Trio Laser Systems have not been subject to a design related recall.### DEVICE DESCRIPTION:

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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). ●

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.

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Table: Comparison of Technological Characteristics

	Cleared Devices	Subject Devices:
	Selecta Duet and Trio Laser
Systems (K081704)	Selecta Duet LED, Digital Duet,
LED Trio, and Digital Trio Laser
Systems
	GENERAL
Manufacturer	Lumenis, Inc.	Lumenis Be, Inc.
Regulation
Number	21CFR§878.4810	Same
Regulation
Name	Powered Laser Surgical Instrument	Same
Procodes	GEX and HQF	Same
Indications
for Use	• Selecta 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), and discission of
pupillary membranes (pupillary
membranectomy) in aphakic and
pseudophakic patients, and
iridotomy/iridectomy and selective
laser trabeculoplasty.
• Selecta Trio: Photodisruption of
ocular tissue using light energy
emitted by a Nd:YAG laser,
including discission of the posterior
capsule of the eye (posterior
capsulotomy), and discission of
pupillary membranes (pupillary
membranectomy) in aphakic and
pseudophakic patients, and
iridotomy/iridectomy, retinal
photocoagulation and selective
laser trabeculoplasty.	• 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:YAG laser, including
discission of the posterior capsule
of the eye (posterior
capsulotomy), iridotomy/
iridectomy, retinal
photocoagulation, and selective
laser trabeculoplasty.
LASER SPECIFICATIONS
Type	Frequency-doubled/Q-switched
Nd:YAG	Identical
	Cleared Devices	Subject Devices:
	Selecta Duet and Trio Laser
Systems (K081704)	Selecta Duet LED, Digital Duet,
LED Trio, and Digital Trio Laser
Systems
Principal
output -
wavelength	532 and 1064 nm	Identical
Operating
mode	Frequency doubled/Fundamental,
pulsed	Identical
Pulse
duration	3 nanoseconds	Identical
Energy (mJ)	For 532 nm laser: 2 maximum
For 1064 nm laser: 30 maximum	Identical
Laser beam
spot size	For 532 nm laser:
400 um at visual focal plane
For 1064 nm laser: