Who is the manufacturer of Phototherapy System (OL-PDT950)?

Shanghai Omni Laser Skinology Co., Ltd. filed the 510(k) submission for Phototherapy System (OL-PDT950) (K230342).

What is the FDA product code for Phototherapy System (OL-PDT950)?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Phototherapy System (OL-PDT950)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Phototherapy System (OL-PDT950)?

Photodynamic Therapy System (K200751); LED Light Therapy Device (K222751); Oxylight (K200104).

Who can help prepare an FDA 510(k) submission like Phototherapy System (OL-PDT950)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Phototherapy System (OL-PDT950)

K230342 · Shanghai Omni Laser Skinology Co., Ltd. · GEX · Aug 16, 2023 · General, Plastic Surgery

Device Facts

Record ID	K230342
Device Name	Phototherapy System (OL-PDT950)
Applicant	Shanghai Omni Laser Skinology Co., Ltd.
Product Code	GEX · General, Plastic Surgery
Decision Date	Aug 16, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Phototherapy System (OL-PDT950) is a vertical LED-based device for aesthetic and dermatological management. It utilizes five LED panels to emit red (633nm), blue (469nm), and infrared (835nm) light. The device is operated by healthcare professionals in a clinical setting. The operator uses a display screen interface to select treatment parameters. The device emits light energy onto the patient's skin at a working distance of 10-15cm for a recommended 20-minute session. The output energy is intended to treat acne, vascular/pigmented lesions, or provide temporary relief for musculoskeletal pain and stiffness. The device does not involve complex AI/ML processing; it functions as a therapeutic light source.

Clinical Evidence

No clinical data was provided. Substantial equivalence is supported by non-clinical bench testing, including electrical safety, electromagnetic compatibility, photobiological safety, and performance testing per IEC standards.

Technological Characteristics

Vertical LED-based phototherapy system. Emits red (633±15nm), blue (469±15nm), and infrared (835±15nm) light via five LED panels. Power supply: 100-240V AC, 50/60Hz, 440VA. Working distance: 10-15cm. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-57 (non-laser light source performance), IEC 62471 (photobiological safety).

Indications for Use

Indicated for patients with moderate inflammatory acne vulgaris (blue light), superficial benign vascular and pigmented lesions (red light), and minor muscle/joint pain, arthritis, muscle spasms, stiffness, and need for increased local blood circulation (infrared light).

Regulatory Classification

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.

Predicate Devices

Photodynamic Therapy System (K200751)
LED Light Therapy Device (K222751)
Oxylight (K200104)

Related Devices

K190938 — Phototherapy System · Shanghai Apolo Medical Technology Co., Ltd. · Jun 26, 2019
K200751 — Photodynamic Therapy (PDT) Equipment · Shangdong Huamei Technology Co., Ltd. · May 21, 2020
K243993 — Photon Therapy Apparatus (BL-10) · Xemis Medical Technology (Shenzhen) Co., Ltd. · Mar 13, 2025
K233077 — FlashHeal 2 (FlashHeal 2.0) · Inwound Aps · Jan 18, 2024
K200659 — Dermalux Tri-Wave MD · Aesthetic Technology, Ltd. · May 9, 2020

Submission Summary (Full Text)

{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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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, {4}------------------------------------------------ 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". {5}------------------------------------------------ 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 {6}------------------------------------------------ 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: 20~96 mW/cm² | Red light: 100mW/cm² | | | Blue light: 35 mW/cm² | Blue light: 120 mW/cm² | Blue light: 10~120 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 | {7}------------------------------------------------ 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.