(87 days)
Not Found
No
The summary describes a standard Intense Pulsed Light (IPL) system with optical filters and focuses on its physical properties, safety standards, and bench testing results. There is no mention of AI, ML, image processing, or any data-driven algorithms for diagnosis, treatment planning, or device control.
Yes
The device is intended for medical use in the treatment of various conditions, including inflammatory acne, benign pigmented and vascular lesions, and permanent hair reduction, which are all therapeutic applications.
No
The device is described as an Intense Pulsed Light System intended for treating various skin conditions, not for diagnosing them. Its purpose is therapeutic (treatment), not diagnostic.
No
The device description explicitly states it is an "Intense Pulsed Light (IPL) System," which is a hardware-based light source equipment with optical filters and specific wavelength spectrums. The performance studies also focus on verifying optical energy output and electrical safety, further indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to treating conditions directly on the human body (acne, pigmented lesions, vascular lesions, hair reduction). IVDs are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description focuses on the light source and its application in non-ablative therapies on skin tissue. This aligns with a therapeutic device, not a diagnostic one that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
This device is clearly a therapeutic device that uses light energy to treat various skin conditions.
N/A
Intended Use / Indications for Use
The Intense Pulsed Light System is intended for medical use in the treatment of the following conditions:
- Moderate inflammatory acne vulgaris;
- Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
- Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations;
- Permanent hair reduction-long-term stable reduction in number of hairs re-growing after a treatment regimen.
Product codes
ONF
Device Description
Intense Pulsed light (IPL) System is a type of intensive, broadband, coherent light source which has a wavelength spectrum of 420 nm -1200 nm. There are six optical filters that can be using in this system listed in table. With these special properties, the IPL System has a wide application in non-ablative therapies based on theory of human skin tissue's selective absorption.
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The Intense Pulsed Light System has been determined through engineering testing to verify optical energy output and electrical safety.
Electrical safety and electromagnetic compatibility:
The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2020 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems
IEC 60601-2-57 Edition 1.0 2011-01 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
Bench testing:
Intense Pulsed Light system is an Light source equipment. The spatial variation of the LS equipment output over the treatment area shall not deviate from the average irradiance or radiant exposure by more than ±20%
The product fulfills the requirements of IEC 60601-2-57.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 and Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a square and the name in a sans-serif font.
May 17, 2024
Smedtrum Medical Technology Co., Ltd. Crimson Wu Senior Regulatory Engineer 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist. New Taipei City, 248016 Taiwan
Re: K240482
Trade/Device Name: Intense Pulsed Light System (ST-690) 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: ONF Dated: February 16, 2024 Received: February 20, 2024
Dear Crimson Wu:
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 (the 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 available 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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Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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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-devices/deviceadvice-comprehensive-regulatory-assistance/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.
Tanisha L. Digitally signed by Hithe -S - Date: 2024.05.17
15:10:25 -04'00'
Tanisha Hithe 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) K240482
Device Name Intense Pulsed Light System (ST-690)
| Indications for Use (Describe) | |
|---|---|
| -------------------------------- | -- |
The Intense Pulsed Light System is intended for medical use in the treatment of the following conditions:
-
Moderate inflammatory acne vulgaris;
-
Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
-
Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations;
-
Permanent hair reduction-long-term stable reduction in number of hairs re-growing after a treatment regimen.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/1 description: The image shows a logo for a medical company. The logo features a stylized blue and gray geometric shape resembling a stylized letter "S" or a medical symbol. To the right of the symbol, there is text in Chinese characters followed by the word "Smart" in a modern sans-serif font. Below "Smart", the word "MEDICAL" is written in smaller letters.
510(k) Summary: K240482 Intense Pulsed Light System
SUBMITTER I.
Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016, Taiwan (R.O.C.) Contact Person
Crimson Wu Position: Senior Regulatory Engineer Tel: +886-2-2298-9578, Ext. 301 Fax: +886-2-2298-9426 E-mail: crimsonwu@smedtrum.com Date of preparation: May 17th, 2024
II. DEVICE
| Trade Name: | Intense Pulsed Light System |
|---|---|
| Common or Usual Name: | Intense Pulsed Light System |
| Product code: | ONF |
| Classification Name: | Powered Light Based Non-Light Surgical Instrument |
| With Thermal Effect |
21 C.F.R. § 878.4810, Device Class II
PREDICATE DEVICE III.
| Manufacturer | Smedtrum Medical Technology Co., Ltd. |
|---|---|
| Trade Name: | Intense Pulsed Light System |
| Common or Usual Name: | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology | |
| Classification Name: | Powered Light Based Non-Light Surgical Instrument |
| With Thermal Effect | |
| 21 C.F.R. § 878.4810, Device Class II | |
| Premarket Notification: | K231394 Aug 9th, 2023 |
IV. DEVICE DESCRIPTION
Intense Pulsed light (IPL) System is a type of intensive, broadband, coherent light source which has a wavelength spectrum of 420 nm -1200 nm. There are six optical filters that can be using in this system listed in table. With these special properties, the IPL System has a wide application in non-ablative therapies based on theory of human
5
Image /page/5/Picture/1 description: The image contains a logo for Smedtrum Medical Technology Co., LTD. The logo features a stylized "S" shape in shades of blue and gray on the left side. To the right of the shape is the company name, "Smedtrum," in a light gray sans-serif font, with the words "MEDICAL TECHNOLOGY CO.,LTD." in smaller letters below. Above the company name is the company name in Chinese.
skin tissue's selective absorption.
| Spectra | Application areas | Expected Working Life |
|---|---|---|
| 420 -1200mm | Acne | 100,000 shots |
| 510 -1200mm | Acne, vascular, pigment | 80,000 shots |
| 560 -1200nm | Vascular, pigmentation | 70,000 shots |
| 610 -1200mm | Hair removal | 60,000 shots |
| 640 -1200nm | Hair removal | 50,000 shots |
| 610 – 980nm (SHR) | Hair removal | 30,000 shots |
V. INDICATIONS FOR USE
The Intense Pulsed Light System is intended for medical use in the treatment of the following conditions:
-
- Moderate inflammatory acne vulgaris;
-
Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
-
Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations;
-
Permanent hair reduction-long-term stable reduction in number of hairs re-growing after a treatment regimen.
COMPARISON OF TECHNOLOGICAL CHARATERISTICS WITH THE PREDICATE DEVICE
| Feature | Proposed device | Predicate device
(K231394) |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Intense Pulsed Light System | Intense Pulsed Light System |
| Product Code | ONF | ONF |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Device Class | Class II | Class II |
| Feature | Proposed device | Predicate device
(K231394) |
| Indication for
Use | The Intense Pulsed Light
System is intended for medical
use in the treatment of the
following conditions: | The Intense Pulsed Light System is
intended for medical use in the
treatment of the following
conditions: |
| | 1. Moderate inflammatory acne
vulgaris; | 1. Moderate inflammatory acne
vulgaris; |
| | 2. Benign pigmented epidermal
lesions including dyschromia,
hyperpigmentation, melasma,
ephelides (freckles); | 2. Benign pigmented epidermal
lesions including dyschromia,
hyperpigmentation, melasma,
ephelides (freckles); |
| | 3. Benign cutaneous vascular
lesions including port wine
stains, hemangiomas, facial
truncal and leg telangiectasias,
erythema of rosacea, leg veins,
spider angiomas and venous
malformations; | 3. Benign cutaneous vascular
lesions including port wine stains,
hemangiomas, facial truncal and
leg telangiectasias, erythema of
rosacea, leg veins, spider angiomas
and venous malformations; |
| | 4. Permanent hair reduction-
long-term stable reduction in
number of hairs re-growing
after a treatment regimen. | 4. Permanent hair reduction-long-
term stable reduction in number
of hairs re-growing after a
treatment regimen. |
| Light Source | Intense Pulsed light (Xenon | Intense Pulsed light (Xenon Flash |
| | Flash Lamp) | Lamp) |
| Wavelength | 420 – 1200 nm | 420 – 1200 nm |
| Light Delivery
System | Handpiece | Handpiece |
| Filter | 420 -1200nm: Acne;
510 -1200nm: Acne, vascular,
pigment;
560 -1200nm: Vascular,
pigment;
610-1200nm: Hair removal;
640-1200nm: Hair removal;
610-980nm: Hair removal; | 420 -1200nm: Acne;
510 -1200nm: Acne, vascular,
pigment;
560 -1200nm: Vascular, pigment;
610-1200nm: Hair removal;
640-1200nm: Hair removal;
610-980nm: Hair removal; |
| Fluence | 420 -1200nm: 4.1-34.8 J/cm²;
510 -1200nm: 3.8-31.6 J/cm²;
560 -1200nm: 3.9-30.2 J/cm²;
610-1200nm: 3.9-27.8 J/cm²;
640-1200nm: 3.3-24.9 J/cm²;
610-980nm: 3.2-23.3 J/cm²; | 420 -1200nm: 4.1-34.8 J/cm²;
510 -1200nm: 3.8-31.6 J/cm²;
560 -1200nm: 3.9-30.2 J/cm²;
610-1200nm: 3.9-27.8 J/cm²;
640-1200nm: 3.3-24.9 J/cm²;
610-980nm: 3.2-23.3 J/cm²; |
| Pulsed Energy
density | 4.135 J/cm² (1050 Level) | 4.135 J/cm² (1050 Level) |
| Pulsed width | 520 ms | 520 ms |
| Feature | Proposed device | Predicate device
(K231394) |
| Pulsed
duration | 550 ms | 550 ms |
| Spot Size | 12 mm × 35 mm &
15 mm × 50 mm | 12 mm × 35 mm &
15 mm × 50 mm |
| Cooling | water + air + TEC | water + air + TEC |
| Appearance | Height 451 mm | Height 1190 mm |
| | Width 468 mm | Width 590 mm |
| | Depth 630 mm | Depth 550 mm |
| | Weight Approx. 45 kg | Weight Approx. 68 kg |
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Image /page/6/Picture/6 description: The image contains the logo for Smedtrum Medical Technology Co. LTD. The logo features the company name in both Chinese and English. The English name "Smedtrum" is prominently displayed in a large, modern font, while the Chinese name, 巨興醫學科技股份有限公司, is above it in a smaller font. To the left of the text is an abstract graphic of teal-colored geometric shapes.
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Image /page/7/Picture/1 description: The image contains a logo for Smedtrum Medical Technology Co., Ltd. The logo features a stylized geometric shape in shades of blue and gray on the left. To the right of the shape is the company name, "Smedtrum," in a light blue sans-serif font, with the words "MEDICAL TECHNOLOGY CO., LTD." in smaller, gray font below it.
VI. PERFORMANCE DATA
The Intense Pulsed Light System has been determined through engineering testing to verify optical energy output and electrical safety.
Electrical safety and electromagnetic compatibility
The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2020 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems
IEC 60601-2-57 Edition 1.0 2011-01 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
Bench testing
Intense Pulsed Light system is an Light source equipment. The spatial variation of the LS equipment output over the treatment area shall not deviate from the average irradiance or radiant exposure by more than ±20%
The product fulfills the requirements of IEC 60601-2-57.
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Image /page/8/Picture/1 description: The image shows the logo for Smedtrum Medical Technology Co., LTD. The logo consists of a geometric shape in shades of blue and gray on the left, followed by the company name in Chinese and English. The word "Smedtrum" is in a larger font size and is colored in light blue and gray.
VII. CONCLUSION
The Intense Pulsed Light System (ST-690) has the same intended use, same indications for use, the same technological characteristics, the same energy used, and the same operating principles as its predicates. The non-clinical data and performance testing reports in this submission demonstrate that Intense Pulsed Light System meets the expected performance requirements. ST-690 is designed in Tabletop using without caster, but predicate device is designed in Standing using with moving by caster. ST-690 can only setup one handpiece on the device. There is no big difference in intended use or indications for use for the Intense Pulsed Light System. Any difference between the subject and predicate device do not raise new issues of safety or effectiveness. Based on above analysis, the Intense Pulsed Light System is as safe, as effective, and performs as well as the cited predicate device.