(189 days)
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.
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.
Based on the provided FDA 510(k) summary for the Phototherapy System (OL-PDT950) (K230342), here's an analysis of the acceptance criteria and the study proving the device meets them:
Important Note: This document is a 510(k) summary for a premarket notification, which demonstrates substantial equivalence to existing devices. It is not a clinical study report that would typically detail the comprehensive acceptance criteria and performance data for a novel device or a device requiring de novo classification. Therefore, the information related to clinical performance is limited, and many of the requested items (e.g., sample size for test set, expert qualifications, MRMC study, ground truth establishment) are generally not part of a 510(k) submission for this type of device.
Acceptance Criteria and Device Performance for Phototherapy System (OL-PDT950)
The device, a Phototherapy System, is intended to emit energy to treat dermatological conditions using red, blue, and infrared light. For a 510(k) submission of this nature, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices. This is achieved through a comparison of technological characteristics and performance specifications. Clinical efficacy is typically established through a combination of the predicate device's history of safe and effective use and non-clinical performance testing of the new device.
The study proving the device meets acceptance criteria is primarily composed of non-clinical tests and a comparison of technical specifications to predicate devices. Clinical testing was not performed for this specific submission as stated in Section 6.1.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for substantial equivalence based on non-clinical data, the "acceptance criteria" are the demonstration of comparable technical specifications and compliance with relevant safety and performance standards. The "reported device performance" are the results of these non-clinical tests and the listed specifications of the subject device.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Subject Device (OL-PDT950) Reported Performance/Specifications | Reference Predicate Devices (K200751, K2227551, K200104) |
|---|---|---|
| Compliance with Electrical Safety Standard | Comply with IEC 60601-1 and IEC 60601-1-2 | Predicates also comply with IEC 60601-1 and IEC 60601-1-2 |
| Compliance with Non-Laser Light Source Equipment Safety Standard | Comply with IEC 60601-2-57 | Predicates also comply with IEC 60601-2-57 |
| Compliance with Photobiological Safety Standard | Comply with IEC 62471 | Predicates also comply with IEC 62471 |
| Software Verification and Validation (if applicable) | Software testing conducted in accordance with FDA guidance. | (Implicit in general controls for all medical devices with software) |
| Wavelengths | Red light: 633nm ± 15nm Blue light: 469nm ± 15nm Infrared light: 835nm ± 15nm | Predicate 1: Red 630±15nm, Blue 415±15nm, IR 835±15nm Predicate 2: Red 633±15nm, Blue 417±15nm, IR 835±15nm Predicate 3: Red 625nm±5nm, Blue 465nm±5nm, Yellow 590nm±5nm (note: Yellow not on subject device) |
| Maximum Power Density (Irradiance) | Red light: 75 mW/cm² Blue light: 35 mW/cm² IR: 120 mW/cm² | Predicate 1: Red 115 mW/cm², Blue 120 mW/cm², IR 70 mW/cm² Predicate 2: Red 20-96 mW/cm², Blue 10-120 mW/cm², IR ≤ 70 mW/cm² Predicate 3: Red 100 mW/cm², Blue 45 mW/cm², Yellow 35 mW/cm² |
| Treatment Area | 1228 cm² | Predicate 1: 1410 cm² Predicate 2: 900 cm² ± 10% Predicate 3: 500cm² and 860cm² |
| Recommended Treatment Time | 20 minutes | Predicates all list 20 minutes |
| Working Distance | 10-15cm | Predicate 1: 10-15cm Predicate 2 & 3: Unknown |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable for clinical data, as stated in Section 6.1: "Clinical testing was not performed for the subject device as part of the submission."
- Data Provenance: The reported performance data for the subject device comes from non-clinical tests (e.g., electrical safety, electromagnetic compatibility, photobiological safety, and performance specifications adherence). The location of these tests is not explicitly stated but can be inferred to be China, given the manufacturer's location (Shanghai, China). The data is inherently prospective in terms of the specific device's specifications and test results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. As clinical testing was not performed, there was no "ground truth" derived from expert consensus on medical conditions for a test set. Normative data for device specifications and compliance with standards are established through engineering and testing professionals, not medical experts.
4. Adjudication method for the test set
- Not applicable. There was no clinical test set requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a phototherapy system, not an AI-powered diagnostic or assistive tool for human readers (like radiologists interpreting images). Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithmic device. Its performance is based on its physical light emission characteristics.
7. The type of ground truth used
- For the non-clinical tests and technical specifications, the "ground truth" is established through objective measurements (e.g., power meters for irradiance, spectrophotometers for wavelength verification) and compliance with internationally recognized consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 62471). There is no "pathology" or "outcomes data" ground truth used for this type of 510(k) submission.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning algorithm, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for this device.
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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.
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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 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, SongjiangDistrict, 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 TherapySystem | LED Light Therapy Device | OxyLight |
| Product Code | GEX | GEX | GEX | GEX |
| Indications for use | The Phototherapy Systemuse of the red, blue andinfrared regions of thespectrum is intended toemit energy to treatdermatological conditions.The blue light (469nmwavelength) is generallyindicated to treatdermatological conditionsand specifically indicated totreat moderateinflammatory acne vulgaris.The red light (633nmwavelength) is generallyindicated to treatment ofsuperficial, benign vascular,and pigmented lesions.The infrared light (835nmwavelength) is generallyuse for the temporary reliefof minor muscle and jointpain, arthritis and musclespasm; relieving stiffness;promoting the relaxation of | The Photodynamic Therapy(PDT) Equipment use ofthe red, blue and infraredregions of the spectrum isintended to emit energy totreat dermatologicalconditions.The blue light (415nmwavelength) is generallyindicated to treatdermatological conditionsand specifically indicated totreat moderateinflammatory acne vulgaris.The red light (630nmwavelength) is generallyindicated to treatment ofsuperficial, benign vascular,and pigmented lesions.The infrared light (835nmwavelength) is generallyuse for the temporary reliefof minor muscle and jointpain, arthritis and musclespasm; relieving stiffness; | LED Light Therapy Deviceuse of the red, blue, Yellowand infrared regions of thespectrum is intended toemit energy to treatdermatological conditions.The red light (633±10nmwavelength) is generallyindicated to treatment ofsuperficial, benign vascular,and pigmented lesions.The blue light (417±10 nmwavelength) is generallyindicated to treatdermatological conditionsand specifically indicated totreat moderateinflammatory acne vulgaris.The Yellow light(599±10nm wavelength) isgenerally indicated to treatdermatological conditionsand specifically indicatedfor treatment of periorbitalwrinkles and rhytides. | The Oxylight is intendedfor dermatological use byphysicians and healthcareprofessionals for thefollowing:LED Technology isintended for:Blue LED - 465nm - totreat dermatologicalconditions and specificallyindicated to treat moderateinflammatory acne vulgaris.Red LED 625nm - fortreatment of superficial,benign vascular andpigmented lesions.Yellow LED 590nm -treatment of periorbitalwrinkles 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 totemporarily increase localblood circulation whereapplied. | promoting the relaxation ofmuscle tissue; and totemporarily increase localblood circulation whereapplied. | The infrared light(835±15nm wavelength) isgenerally use for thetemporary relief of minormuscle and joint pain,arthritis and muscle spasm;relieving stiffness;promoting the relaxation ofmuscle tissue; and totemporarily increase localblood circulation whereapplied. |
|---|---|---|
| -------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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±15nmBlue light 469nm±15nmInfrared light 835nm±15nm | Red light 630±15Blue light 415±15Infrared light 835±15 | Red light 633nm±15nmBlue light 417nm±15nmInfrared light 835nm±15nm | Red light 625nm±5nmBlue light 465nm±5nmYellow light 590nm±5nm |
| Panels Type | 5 panels: 2400 EA LEDs.The panels may emit thethree light (red, blue,infrared)Blue: 800EA,Red: 800EA,Infrared: 800EA | 5panel: 300 EA LEDs.The panels may emit thethree light (red, blue,infrared) | RBY Irradiator has 5 panels:Red light:465EA LEDs;blue light: 470EA LEDs;yellow light: 465EA LEDs;RBI irradiator: has 5panels:Red light:465EA LEDs;blue light: 470EA LEDs;infrared: 465EA LEDs; Thepanels may emit the threelight (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 threedifferent 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: 10~120mW/cm² | Blue light: 45 mW/cm² | |
| Maximumpowerdensity | 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) | |
| Workingdistance | 10~15cm | 10~15cm | Unknown | Unknown |
| Power supply | AC100-240V50/60Hz440VA | AC100-240V50/60Hz440VA | AC 100-240V 50/60Hz | Unknown |
| Operationinterface | Display Screen | Display Screen | Display Screen | Display Screen |
| ElectricalSafety | Comply with IEC 60601-1and IEC 60601-1-2 | Comply with IEC 60601-1and IEC 60601-1-2 | Comply with IEC 60601-1and IEC 60601-1-2 | Comply with IEC 60601-1and 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 |
| Photobiologicalsafety | 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.
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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.
§ 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.