Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a laser system for ophthalmic treatment and does not mention any AI or ML components or functionalities.

Therapeutic

Yes
The device is indicated for the treatment of Clinically Significant Macular Edema (CSME) by producing a wound to the Retinal Pigmented Epithelium (RPE) of the eye, which is a therapeutic intervention.

Diagnostic

No

The device is described as a surgical laser system used by ophthalmic physicians to produce a wound to the Retinal Pigmented Epithelium (RPE) of the retina, for the treatment of certain retinal diseases. Its function is to treat, not to diagnose.

SaMD (Software as a Medical Device)

No

The device description clearly lists multiple hardware components including a Main Body containing a laser, LCD Monitor, Slit Lamp Set, Footswitch, and Real Time Feedback Contact Lens, indicating it is a hardware-based system with integrated software, not a software-only device.

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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
R:GEN Function: The R:GEN is a surgical laser system that directly treats the retina within the patient's eye. It produces a wound to the Retinal Pigmented Epithelium (RPE) via focal laser treatment. This is a therapeutic intervention performed in vivo (within the living body).

The description clearly indicates a device used for direct treatment of a condition within the eye, not for analyzing samples taken from the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The R:GEN is indicated for use by an ophthalmic physician to produce a wound to the Retinal Pigmented Epithelium (RPE) of the retina of the eye, via focal laser treatment of Clinically Significant Macular Edema (CSME).

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

HQF

Device Description

The R:GEN is a surgical laser system for use by ophthalmic physicians for performing focal laser treatment, also referred to as selective retinal therapy for the treatment of various retinal diseases by wounding Retinal Pigmented Epithelium (RPE) cells. It is the product of continual technological evolution of the R:GEN technology described in the predicate device (K153769). It consists of the following main components: Main Body, LCD Monitor, Slit Lamp Set, Footswitch, and Real Time Feedback (RTF) Contact Lens which consists of the RTF Body (Real Time Feedback Body) and RTF Sensor (Real Time Feedback Sensor). The Main Body allows the proper operation of the entire system. It contains the laser and is attached to the Footswitch and optical fiber. The laser is a Q-switched Nd:YLF (Neodymium-doped Yttrium Lithium Fluoride) laser with an emission wavelength of 527 nm (produced by second-harmonic generation). The integrated software provides all the functions which are necessary to use the device. The Slit Lamp Set contains the laser delivery system. The laser beam emitted through the Slip Lamp Set is transmitted through the RTF Contact Lens (first through the RTF body and then through the RTF Sensor), and finally irradiated to the patient's retina.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Retinal Pigmented Epithelium (RPE) of the retina of the eye

Indicated Patient Age Range

Adult

Intended User / Care Setting

ophthalmic physician

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)

Bench Testing: Biocompatibility testing of patient contacting material, Sterilization testing and shelf life validation of the RTF Sensor, Software Verification and Validation, Electromagnetic Compatibility (EMC) and Electrical Safety testing.
Animal Testing: An animal studies were performed with the R:GEN that established that the use of subject device wounds RPE cells.
Clinical Evidence: Published clinical performance testing established that the subject device performs as intended in the treatment of CSME.

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.

K153769

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.

K122202, K121475, K123542

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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

December 27, 2022

Lutronic Vision, Inc. % Dulciana Chan Principal Consultant Ram+ 2251 San Diego Avenue, Suite B-257 San Diego, California 92110

Re: K220974

Trade/Device Name: R:gen Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: November 23, 2022 Received: November 25, 2022

Dear Dulciana Chan:

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.

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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 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 531-542 of the Act); 21 CFR 1000-1050.

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 mediation-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.

Alexander Date: 2022.12.27 Beylin -S 17:58:40 -05'00'

for Elvin Ng, 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

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Indications for Use

510(k) Number (if known) K220974

Device Name R:GEN

Indications for Use (Describe)

The R:GEN is indicated for use by an ophthalmic physician to produce a wound to the Retinal Pigmented Epithelium (RPE) of the retina of the eye, via focal laser treatment of Clinically Significant Macular Edema (CSME).

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K220974

DATE PREPARED

December 22, 2022

510(k) OWNER

Lutronic Vision Inc. 19 Fortune Drive Billerica, MA 01821 Telephone: Official Contact: Haelyung Hwang, CEO

REPRESENTATIVE/CONSULTANT

Dulciana Chan, MSE Allison C. Komiyama, Ph.D., R.A.C. RQM+ Telephone: +1 (412) 816-8253 Email: dchan@rqmplus.com, akomiyama@rqmplus.com

DEVICE INFORMATION

Proprietary Name/Trade Name: R:GEN Common Name: Laser, Ophthalmic Regulation Number: 21 CFR § 886.4390 Class: II Product Code: HQF Premarket Review: OPEQ/OHT1/DHT1A/Retinal and Diagnostic Devices Review Panel: Ophthalmic

PREDICATE DEVICE IDENTIFICATION

The R:GEN is substantially equivalent to the following predicate:

510(k) Number	Predicate Device Name / Manufacturer	Primary Predicate
K153769	R:GEN Laser System	✓

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Lutronic submits the following information to demonstrate that the R:GEN has similar technology to the following legally marketed reference devices:

510(k) Number	Reference Device Name / Manufacturer	Reference Device
K122202	Ellex 2RT /Ellex Medical	✓
K121475	TxCell Scanning Laser Deliver System /IRIDEX Corporation	✓
K123542	Pascal Synthesis Ophthalmic Laser/ IRIDEX Corporation	✓

DEVICE DESCRIPTION

The R:GEN is a surgical laser system for use by ophthalmic physicians for performing focal laser treatment, also referred to as selective retinal therapy for the treatment of various retinal diseases by wounding Retinal Pigmented Epithelium (RPE) cells. It is the product of continual technological evolution of the R:GEN technology described in the predicate device (K153769). It consists of the following main components: Main Body, LCD Monitor, Slit Lamp Set, Footswitch, and Real Time Feedback (RTF) Contact Lens which consists of the RTF Body (Real Time Feedback Body) and RTF Sensor (Real Time Feedback Sensor). The Main Body allows the proper operation of the entire system. It contains the laser and is attached to the Footswitch and optical fiber. The laser is a Q-switched Nd:YLF (Neodymium-doped Yttrium Lithium Fluoride) laser with an emission wavelength of 527 nm (produced by second-harmonic generation). The integrated software provides all the functions which are necessary to use the device. The Slit Lamp Set contains the laser delivery system. The laser beam emitted through the Slip Lamp Set is transmitted through the RTF Contact Lens (first through the RTF body and then through the RTF Sensor), and finally irradiated to the patient's retina.

INDICATIONS FOR USE

The R:GEN is indicated for use by an ophthalmic physician to produce a wound to the Retinal Pigmented Epithelium (RPE) of the retina of the eye, via focal laser treatment of Clinically Significant Macular Edema (CSME).

INTENDED USE

The subject device has the same intended use as the predicate device which is to produce a wound to the Retinal Pigmented Epithelium (RPE) of the retina of the eye.

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SUBSTANIAL EQUIVALENCE

	Subject Device	Predicate Device	Reference Device	Reference Device	Reference Device		2 x 2 Combo Pattern			Rotation	Triple Ring
Intended
Use	Lutronic Vision
Inc.
R:GEN
K220974	Lutronic
Corporation
R:GEN Laser
System
K153769	Ellex Medical
Ellex 2RT
K122202	IRIDEX Corporation
TxCell Scanning Laser
Delivery System
K121475	IRIDEX Corporation
Pascal Synthesis
Ophthalmic Laser
K123542					Arc	Arc
Indications
for Use	To produce a wound
to the Retinal
Pigmented
Epithelium (RPE) of
the retina of the eye	To produce a wound
to the Retinal
Pigmented Epithelium
(RPE) of the retina of
the eye	To produce a
wound to the
Retinal Pigmented
Epithelium (RPE) of
the retina of the
eye	To deliver laser energy to
various ocular targets	To deliver laser energy to
various ocular targets					Triple Arc	Line (1-10 spots in a line)
Indications
for Use	The R:GEN is
indicated for use by
an ophthalmic
physician to
produce a wound to
the Retinal
Pigmented
Epithelium (RPE) of
the retina of the
eye, via focal laser
treatment, in the
treatment of
Clinically Significant
Macular Edema
(CSME).	The R:GEN Laser
System is indicated
for use by an
ophthalmic physician
to produce a wound
to the Retinal
Pigmented Epithelium
(RPE) of the retina of
the eye, via focal laser
treatment, in the
treatment of Clinically
Significant Macular
Edema (CSME)	The 2RT (LR1532) is
indicated for use by
a trained
ophthalmic
physician to
produce a wound
to the Retinal
Pigmented
Epithelium (RPE) of
the retina of the
eye, via focal laser
treatment, in the
treatment of
Clinically Significant
Macular Edema
(CSME)	When the TxCell Scanning
Laser Delivery System is
connected to the IQ 532
(532 nm), the IQ 577 (577
nm) or the IQ 810 (810
nm) Laser Console, from
the IRIDEX
Family of IQ Laser Systems
and used to deliver laser
energy in CW-Pulse,
MicroPulse or LongPulse
mode, it is intended to be
used by a trained
ophthalmologist for the
treatment of ocular
pathology of both the
anterior and posterior
segments of the eye.
532 nm
Indicated for retinal
photocoagulation laser	The PASCAL® Synthesis
Ophthalmic Scanning Laser
System is intended for use in
the treatment of ocular
pathology in both the posterior
and anterior segments.
Intended for use in the
posterior segment to perform
retinal photocoagulation,
panretinal photocoagulation.
focal photocoagulation and
grid photocoagulation for
vascular and structural
abnormalities of the retina and
choroid including:
(532 nm)
• proliferative and non-
proliferative diabetic
retinopathy
• macular edema					Circle	Hexagon (6-sided array)
Patient
Population	Adult	Adult	Adult	Adult	Adult						Octant (up to 4 rings divided
Product
Code /	HQF/ 21 CFR
886.4390	HQF/ 21 CFR
886.4390	HQF/ 21 CFR
886.4390	GEX/ 21 CFR 878.4810	HQF/ 21 CFR 886.4390						into 8 radial segments)
				trabeculoplasty,
iridotomy, iridoplasty
including:
Retinal photocoagulation
(RPC) for the treatment
of:
Diabetic retinopathy,
including:
Nonproliferative
retinopathy
Macular edema
Proliferative retinopathy
Retinal tears and
detachments
Lattice degeneration
Age-related macular
degeneration (AMD) with
choroidal
neovascularization (CNV)
Sub-retinal (choroidal)
neovascularization
Central and branch retinal
vein occlusion
Laser trabeculoplasty for
the treatment of:
Primary open angle
glaucoma
Laser iridotomy,
iridoplasty for the
treatment of:
Angle closure glaucoma	choroidal
neovascularization
associated with wet age-
related macular
degeneration age-related macular
degeneration lattice degeneration retinal tears and
detachments
(577nm) proliferative and non-
proliferative diabetic
retinopathy macular edema choroidal
neovascularization
associated with wet age-
related macular
degeneration age-related macular
degeneration lattice degeneration retinal tears and
detachments Intended for use in the
treatment of ocular pathology
in the anterior segment
including:
(532 nm and 577nm) iridotomy
trabeculoplasty						Enhanced Octant (multiple
Regulation
Number											rings from 500-3000 μm
Regulation
Description	Ophthalmic Laser	Ophthalmic Laser	Ophthalmic Laser	Laser surgical instrument
for use in general and
plastic surgery and in
dermatology	Ophthalmic Laser						radius)
Laser Type	Q-switched Nd:YLF
Laser	Q-switched Nd:YLF
Laser	Q-switched Nd:YAG
Laser, frequency
doubled	Frequency doubled solid-
state	Pumped semiconductor
(OPSL); solid-state						Circle (1-3 rings in full or partial
Laser
Wavelength	527 nm (green)	527 nm (green)	532 nm	532 nm, 577 nm, 810 nm	532 nm or 577 nm						circle)
Laser Energy	0.03 mJ to 0.35 mJ	0.03 mJ to 0.4 mJ	Minimum: 0.1 mJ
Maximum: 0.6 mJ
0.10-0.30 in 0.02
steps
0.30-0.60 in 0.05
steps	2W power	0.3mW-2000 mW power	Screen	Touch LCD Module	Touch LCD Module	Tablet	Unknown	Touchscreen LCD Module
Pulse
Duration	1.7 µs	1.7 µs	0.003 μs
No less than 500 ms
for 20 continuous
shots	Variable (≤100ms)	5-1000 ms	Emission	Footswitch	Footswitch	Footswitch	Footswitch	Footswitch
Aiming
Beam	635 nm	635 nm	635 nm	635 nm	635 nm	Control
Type of
Delivery
System	Slit lamp adapter
with optical fiber
connected to a
separate laser
source	Slit lamp adapter with
optical fiber
connected to a
separate laser source	Slit lamp adapter
with optical fiber
connected to a
separate laser
source	Slit lamp adapter with
optical fiber connected to
a separate laser source	Slit lamp adapter with optical
fiber connected to a separate
laser source	Laser	RTF Contact Lens	Laser Contact Lens	Laser Contact Lens	Laser Contact Lens not	Laser Contact Lens not
Single Spot
Size	200 μm	200 μm	400 μm	50-500 μm	50, 100, 200, 400 μm	Contact Lens	provided	not provided	not provided	provided	provided
Multi-spot
Deliver
Modes	Yes
Square Pattern (2x2,
3x3, or 4x4)
Circle Pattern
(radius 500-2000
μm)	No	No	Yes
Multi-spot patterns (100-
500 μm spot sizes)
Radius
Grid (2x2, 3x3, 4x4, 5x5,
6x6,7x7)	Yes Multi-spot patterns (40-
400 µm spot sizes)
Array (1x1 to 5x5 grid)
Triple Arc
Wedge (3-sided 3x3x3 to
6x6x6 segment)	Electrical	AC 100-240V, 50/60	AC 100-240V, 50/60	100-240 VAC,	100-240 VAC, 50/60 Hz	100 - 230 VAC,
Rating	Hz, Power	Hz, Power	50/60 Hz		50/60 Hz
	consumption 300VA	consumption 300VA

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The R:GEN that is the subject of this 510(k) employs the same mechanism of action as the predicate device and achieves its intended use with very similar technological characteristics when compared with the legally marketed predicate and reference devices. Differences in technological characteristics, do not raise difference safety or effectiveness questions and data demonstrates that the R:GEN is as safe and effective as the predicate device for the same intended use. The R:GEN is substantially equivalent to the predicate device based on the information summarized here:

The subject device has a similar design and dimensions, and identical materials as the device cleared in K153769.

The differences in technological characteristics from the predicate include using the same laser technology to provide additional treatment patterns and the use of the Real Time Feedback (RTF) Contact Lens. The subject device offers additional laser treatment patterns including single, square, circle and 2x2 Combo while the predicate device provided a single spot treatment pattern.

The maximum laser energy per pulse for the subject device is lower than the predicate device. The predicate device was designed to deliver a single pulse to the patient with no limitations on the number of pulses to be delivered during a treatment session. The subject device delivers a maximum of 15 pulses per treatment.

The R:GEN subject to this 510(k) has undergone testing to ensure the device is as safe and effective as the predicate for the intended use.

PERFORMANCE DATA

The R:GEN substantially conforms to the performance standards for light emitting products (21 CFR 1040). Bench testing was performed in accordance with IEC 60825-1 Safety of laser products - Part 1: Equipment classification, and requirement and IEC 60601-2-22 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.

Bench Testing

The following tests were performed to demonstrate safety and performance based on current industry standards:

. Biocompatibility testing of patient contacting material in compliance to ISO 10993-1, ISO 10993-5, and ISO 10993-10
Sterilization testing and shelf life validation of the RTF Sensor in compliance to ISO . 11737-1, ISO 10993-7, ISO 11135, and ASTM F1980-16

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Software Verification and Validation were conducted in compliance to IEC 60601-1 and ● IEC 62304. Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Major" level of concern, since a failure or latent flaw could indirectly result in death or serious injury of the patient or operator through incorrect or delayed information or through the action of a care provider.
Electromagnetic Compatibility (EMC) and Electrical Safety testing in compliance to IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and IEC/EN 60601-1-2

Animal Testing

An animal studies were performed with the R:GEN that established that the use of subject device wounds RPE cells. Additional published animal studies showing the safety and effectiveness of the subject were provided.

Clinical Evidence

Published clinical performance testing established that the subject device performs as intended in the treatment of CSME.

CONCLUSION

Based on the testing performed, including biocompatibility, sterilization, shelf life validation, software verification and validation, EMC and electrical safety, bench performance testing, animal testing, and published clinical evidence, it can be concluded that the subject device is able to perform equivalently to the predicate device. The R:GEN has the same indications for use, and technological characteristics, that do not raise different questions of safety and effectiveness and therefore is assessed to be substantially equivalent to the predicate device.