Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a phototherapy device using LEDs at specific wavelengths for dermatological and pain relief applications. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The testing focuses on electrical safety, electromagnetic compatibility, and photobiological safety, not performance metrics typically associated with AI/ML.

Therapeutic

Yes
The device is described as treating dermatological conditions, musculoskeletal pain, and increasing local blood circulation, all of which fall under the scope of therapeutic applications. Furthermore, the device's intended use clearly states it "is intended to emit energy to treat dermatological conditions" and "for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm."

Diagnostic

No

The "Intended Use / Indications for Use" section clearly states that the device is intended to "emit energy to treat dermatological conditions" and for "temporary relief of minor muscle and joint pain, arthritis and muscle spasm". These are therapeutic uses, not diagnostic ones. Diagnostic devices are used to identify or detect a disease or condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "vertical device which uses specific wavelengths of light, produced by LEDs (Light emitting diodes)" and mentions "Five sets of LEDs panels are available for the device." This indicates the device includes significant hardware components (LEDs, panels, and the vertical structure) beyond just software. The performance studies also include testing for electrical safety and photobiological safety, which are relevant to hardware.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the device is used to "emit energy to treat dermatological conditions" and for "temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied." These are therapeutic applications, not diagnostic ones.
Device Description: The description focuses on the physical characteristics of the device and the light it produces, not on any components or processes related to testing samples from the human body.
Lack of IVD Indicators: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro testing.

IVD devices are specifically designed to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to apply light energy to the body for therapeutic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Phototherapy System use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The blue light (469mm wavelength) indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The red light (633nm wavelength) indicated to treatment of superficial, benign vascular, and pigmented lesions.
The infrared light (835nm wavelength) is generally use for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Product codes

GEX

Device Description

The Phototherapy System OL-PDT950 is a vertical device which uses specific wavelengths of light, produced by LEDs (Light emitting diodes), to manage aesthetic conditions.

The device produces light in the red light region of the spectrum (633±15nm), in the blue light regions of the light spectrum (469±15nm) and infrared light region of light spectrum (835±15nm).

Five sets of LEDs panels are available for the device.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

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)

Non-Clinical Tests

The following performance data are provided in support of the substantial equivalence determination:

IEC 60601-1: 2005 + CORR.1:2006 + CORR.2:2007 + A1:2012: Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance;
IEC 60601-1-2: 2014: Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility
IEC60601-2-57:2021: Medical electrical equipment -- Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use:
IEC 62471: 2006: Photobiological safety of lamps and lamp systems.

Software

Software verification and validation testing were conducted and 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".

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

Not Found

Predicate Device(s)

K200751, K222751, K200104

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

Summary

0

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 is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

August 16, 2023

Shanghai Omni Laser Skinology Co., Ltd. % Helen Nan General Manager New Risen Enterprise Management Consulting Co., Ltd. Room 302, Building 3, Hangqian Mansion, Hangqian Street Lucheng District Wenzhou, Zhejiang 325000 China

Re: K230342

Trade/Device Name: Phototherapy System (OL-PDT950) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: July 17, 2023 Received: July 17, 2023

Dear Helen Nan:

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.

1

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 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.

Jianting Wang -S

For Tanisha L. Hithe, MS, MHS Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K230342

Device Name Phototherapy System (OL-PDT950)

Indications for Use (Describe)

he Phototherapy System use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.

The blue light (469mm wavelength) indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The red light (633nm wavelength) indicated to treatment of superficial, benign vascular, and pigmented lesions.

The infrared light (835nm wavelength) is generally use for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows a green shamrock with three leaves. The shamrock is surrounded by a light purple, curved shape that partially encircles it. The background is white.

K230342 510(k) Summary (As required by 21 CFR 807.92)

1.0 Submitter Information

Company:	Shanghai Omni Laser Skinology Co., Ltd.
Address	Floor 3, Building 3, NO. 227, Mingqiang Road, Songjiang
District, Shanghai, 201612, CHINA
Phone:	+86-021-54847192
E-mail:	avril@omni-laser.com
Contact	Avril Ouyang
Title:	General Manager
Prepared date:	07/17/2023

2.0 Device Information

Trade/Device Name:	Phototherapy System
Model:	OL-PDT950
Device:	Powered Laser Surgical Instrument
Review Panel:	General & Plastic Surgery
Product Code:	GEX
Submission Type:	Traditional 510(k)
Regulation Number:	CFR 878.4810
Device Class:	Class II

3.0 Predicate Device Information

Predicate Device 1:
K Number:	K200751
Trade/Device Name:	Photodynamic Therapy System
Submitter:	Shangdong Huamei Technology Co., Ltd.
Predicate Device 2
K Number:	K222751
Trade/Device Name:	LED Light Therapy Device
Submitter:	Xuzhou Kernel Medical Equipment Co., Ltd.
Predicate Device 3
K Number:	K200104
Trade/Device Name:	Oxylight
Submitter:	RAJA Trading Company, Inc.

4.0 Indications for Use

The Phototherapy System use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.

The blue light (469nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The red light (633nm wavelength) is generally indicated to treatment of superficial,

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Image /page/4/Picture/0 description: The image shows a green shamrock with three leaves, which is a symbol often associated with Ireland and Saint Patrick's Day. The shamrock is surrounded by a light purple, incomplete circle, giving it a stylized and somewhat abstract appearance. The overall design is simple and clean, with a focus on the iconic shamrock shape.

benign vascular, and pigmented lesions.

The infrared light (835nm wavelength) is generally use for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

5.0 Device Description

The Phototherapy System OL-PDT950 is a vertical device which uses specific wavelengths of light, produced by LEDs (Light emitting diodes), to manage aesthetic conditions.

The device produces light in the red light region of the spectrum (633±15nm), in the blue light regions of the light spectrum (469±15nm) and infrared light region of light spectrum (835±15nm).

Five sets of LEDs panels are available for the device.

6.0 Discussion of Tests Performed

6.1 Clinical Tests

Clinical testing was not performed for the subject device as part of the submission.

6.2 Non-Clinical Tests

The following performance data are provided in support of the substantial equivalence determination:

IEC 60601-1: 2005 + CORR.1:2006 + CORR.2:2007 + A1:2012: Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance;

IEC 60601-1-2: 2014: Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility

IEC60601-2-57:2021: Medical electrical equipment -- Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use:

IEC 62471: 2006: Photobiological safety of lamps and lamp systems.

7.0 Software

Software verification and validation testing were conducted and 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".

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Image /page/5/Picture/0 description: The image shows a green shamrock inside of a white circle. The white circle is surrounded by a light purple ring. The shamrock is a traditional Irish symbol, often associated with Saint Patrick's Day.

8.0 Comparison of Technological Characteristics with the Predicate Device

Device Feature	Subject Device	Predicate Device 1	Predicate Device 2	Predicate Device 3
K Number	K230342	K200751	K222751	K200104
Name	Phototherapy System	Photodynamic Therapy
System	LED Light Therapy Device	OxyLight
Product Code	GEX	GEX	GEX	GEX
Indications for use	The Phototherapy System
use of the red, blue and
infrared regions of the
spectrum is intended to
emit energy to treat
dermatological conditions.
The blue light (469nm
wavelength) is generally
indicated to treat
dermatological conditions
and specifically indicated to
treat moderate
inflammatory acne vulgaris.
The red light (633nm
wavelength) is generally
indicated to treatment of
superficial, benign vascular,
and pigmented lesions.
The infrared light (835nm
wavelength) is generally
use for the temporary relief
of minor muscle and joint
pain, arthritis and muscle
spasm; relieving stiffness;
promoting the relaxation of	The Photodynamic Therapy
(PDT) Equipment use of
the red, blue and infrared
regions of the spectrum is
intended to emit energy to
treat dermatological
conditions.
The blue light (415nm
wavelength) is generally
indicated to treat
dermatological conditions
and specifically indicated to
treat moderate
inflammatory acne vulgaris.
The red light (630nm
wavelength) is generally
indicated to treatment of
superficial, benign vascular,
and pigmented lesions.
The infrared light (835nm
wavelength) is generally
use for the temporary relief
of minor muscle and joint
pain, arthritis and muscle
spasm; relieving stiffness;	LED Light Therapy Device
use of the red, blue, Yellow
and infrared regions of the
spectrum is intended to
emit energy to treat
dermatological conditions.
The red light (633±10nm
wavelength) is generally
indicated to treatment of
superficial, benign vascular,
and pigmented lesions.
The blue light (417±10 nm
wavelength) is generally
indicated to treat
dermatological conditions
and specifically indicated to
treat moderate
inflammatory acne vulgaris.
The Yellow light
(599±10nm wavelength) is
generally indicated to treat
dermatological conditions
and specifically indicated
for treatment of periorbital
wrinkles and rhytides.	The Oxylight is intended
for dermatological use by
physicians and healthcare
professionals for the
following:
LED Technology is
intended for:
Blue LED - 465nm - to
treat dermatological
conditions and specifically
indicated to treat moderate
inflammatory acne vulgaris.
Red LED 625nm - for
treatment of superficial,
benign vascular and
pigmented lesions.
Yellow LED 590nm -
treatment of periorbital
wrinkles and rhytides.

Table 1 - General Comparison

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Image /page/6/Picture/0 description: The image shows a green shamrock inside of a purple circle. The shamrock is a three-leaf clover, and it is the national symbol of Ireland. The purple circle is slightly blurred, and it appears to be a halo effect around the shamrock. The image is simple and clean, and it is likely used as a logo or icon.

Shanghai Omni Laser Skinology Co., Ltd.

| muscle tissue; and to
temporarily increase local
blood circulation where
applied. | promoting the relaxation of
muscle tissue; and to
temporarily increase local
blood circulation where
applied. | The infrared light
(835±15nm wavelength) is
generally use for the
temporary relief of minor
muscle and joint pain,
arthritis and muscle spasm;
relieving stiffness;
promoting the relaxation of
muscle tissue; and to
temporarily increase local
blood circulation where
applied. |

--------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Table 2 - Performance Comparison

| Device Feature | Subject Device (K230342) | Predicate Device 1
(K200751) | Predicate Device 2
(K222751) | Predicate Device 3
(K200104) |
|-----------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Wavelength
(nm) | Red light 633nm±15nm
Blue light 469nm±15nm
Infrared light 835nm±15nm | Red light 630±15
Blue light 415±15
Infrared light 835±15 | Red light 633nm±15nm
Blue light 417nm±15nm
Infrared light 835nm±15nm | Red light 625nm±5nm
Blue light 465nm±5nm
Yellow light 590nm±5nm |
| | Panels Type | 5 panels: 2400 EA LEDs.
The panels may emit the
three light (red, blue,
infrared)
Blue: 800EA,
Red: 800EA,
Infrared: 800EA | 5panel: 300 EA LEDs.
The panels may emit the
three light (red, blue,
infrared) | RBY Irradiator has 5 panels:
Red light:465EA LEDs;
blue light: 470EA LEDs;
yellow light: 465EA LEDs;
RBI irradiator: has 5
panels:
Red light:465EA LEDs;
blue light: 470EA LEDs;
infrared: 465EA LEDs; The
panels may emit the three
light (red, blue infrared)
individual or in |
| | | | combination | Shanghai Omni Laser Skinology Co., Ltd. |
| LED power | Each LED lamp bead has 1 | Each LED lamp bead has 3 | Each panel has three
different kinds of light-
emitting diodes, and the | Unknown |
| | diodes that emit single | diodes that emit different | energy power of the diode | |
| | color, the energy power of a | colors, the Energy power of | is 0.5W | |
| | diode is: | a diode is 3W. | | |
| | Red light: 120mw | | | |
| | Blue light: 160mw | | | |
| | Infrared light: 100mw | | | |
| | Red light: 75mW/cm² | Red light: 115 mW/cm² | Red light: 2096 mW/cm² | Red light: 100mW/cm² |
| | Blue light: 35 mW/cm² | Blue light: 120 mW/cm² | Blue light: 10120
mW/cm² | Blue light: 45 mW/cm² |
| Maximum
power
density | IR: 120 mW/cm² | IR: 70 mW/cm² | Infrared: ≤ 70 mw/cm² | Yellow light: 35 mW/cm² |
| | | | Red/IR: 166mW/cm² | |
| | | | Blue/IR: 190mW/cm² | |
| Treatment area | 1228 cm² | 1410 cm² | 900 cm²±10% cm² | 500cm² and 860cm² |
| Treatment time | 20 minutes (recommended | 20 minutes (recommended | 20 minutes (recommended | 20 minutes (recommended |
| | Treatment Time) | Treatment Time) | Treatment Time) | Treatment Time) |
| Working
distance | 10~~15cm | 10~~15cm | Unknown | Unknown |
| Power supply | AC
100-240V
50/60Hz
440VA | AC
100-240V
50/60Hz
440VA | AC 100-240V 50/60Hz | Unknown |
| Operation
interface | Display Screen | Display Screen | Display Screen | Display Screen |
| Electrical
Safety | Comply with IEC 60601-1
and IEC 60601-1-2 | Comply with IEC 60601-1
and IEC 60601-1-2 | Comply with IEC 60601-1
and IEC 60601-1-2 | Comply with IEC 60601-1
and IEC 60601-1-2 |
| Radiation Safety | Comply with IEC 60601-2-
57 | Comply with IEC 60601-2-
57 | Comply with IEC 60601-2-
57 | Comply with IEC 60601-2-
57 |
| Photobiological
safety | Comply with IEC 62471 | Comply with IEC 62471 | Comply with IEC 62471 | Comply with IEC 62471 |

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Image /page/7/Picture/0 description: The image shows a green shamrock inside of a light purple circle. The shamrock is a three-leaf clover, and it is positioned in the center of the circle. The circle is not fully closed, and it appears to be a crescent shape. The image is simple and clean, with a focus on the shamrock as the main subject.

8

Image /page/8/Picture/0 description: The image shows a green shamrock with a light purple arc behind it. The shamrock is a three-leaf clover, a symbol often associated with Ireland and Saint Patrick's Day. The arc is positioned behind the shamrock, creating a sense of depth. The image is simple and clean, with a focus on the iconic shamrock symbol.

9.0 Conclusion

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.