(86 days)
Not Found
No
The summary describes a standard IPL system with optical filters and focuses on electrical safety, software validation (moderate level of concern, not indicative of complex AI/ML), biocompatibility, and bench testing of energy output. There is no mention of AI, ML, image processing, or any data-driven decision-making processes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for medical use in treating various conditions such as acne vulgaris, pigmented lesions, vascular lesions, and for permanent hair reduction, all of which are considered therapeutic applications.
No
Explanation: The device is described as an Intense Pulsed Light System intended for treating various medical conditions (acne, pigmented lesions, vascular lesions, hair reduction). Its function is therapeutic, not diagnostic.
No
The device description explicitly states it is an "Intense Pulsed Light (IPL) System" which is a hardware-based technology emitting light. The performance studies also detail testing related to optical energy output, electrical safety, and bench testing of the equipment's output, all indicative of a physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Description and Intended Use: The description and intended use of this Intense Pulsed Light System clearly indicate that it is a device that applies light energy directly to the skin for therapeutic purposes (treating acne, pigmented lesions, vascular lesions, and hair reduction). This is an in vivo (within the living body) application, not an in vitro application.
- Lack of IVD Characteristics: The provided information does not mention any testing of biological samples, analysis of bodily fluids, or any of the typical characteristics of an IVD device.
Therefore, based on the provided information, this Intense Pulsed Light System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Intense Pulsed Light System is intended for medical use in 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 (comma separated list FDA assigned to the subject device)
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
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)
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 IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012, IEC 60601-1-2:2020, IEC 62471 First edition 2006-07, and IEC 60601-2-57 Edition 1.0 2011-01.
Software Verification and Validation Testing: Software verification and validation testing were conducted; the software for this device was considered as a "moderate" level of concern.
Sterilization and Shelf-Life: The proposed device is not provided sterile and does not need to be sterilized. The handpiece and the body are cleaned with a soft cloth moistened with ethanol of 70% strength or higher. The proposed device is reusable and does not have a restricted shelf-life.
Biocompatibility: Three biological effects were determined: Cytotoxicity, Sensitization, and Irritation. The Cytotoxicity test showed that the extract of the test article passed test requirements and did not show potential cytotoxicity. The Skin sensitization test results showed the test article did not cause delayed dermal contact sensitization. The Skin irritation test results showed no erythema and edema findings, and PII values were 0 (Non-irritant).
Bench testing: The product fulfills the requirements of IEC 60601-2-57, with the spatial variation of the LS equipment output over the treatment area not deviating from the average irradiance or radiant exposure by more than +/-20%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
August 9, 2023
Smedtrum Medical Technology Co., Ltd. Crimson Wu Senior Regulatory Engineer 1F., No. 8, Ln. 97, Wugong Rd., New Taipei City, Xinzhuang Dist. 248016 Taiwan
Re: K231394
Trade/Device Name: Intense Pulsed Light System 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: May 12, 2023 Received: May 15, 2023
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 (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.
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
1
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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jianting Wang -S
Jianting Wang 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) K231394
Device Name Intense Pulsed Light System
The Intense Pulsed Light System is intended for medical use in 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) |
|---|
| ------------------------------------------------- |
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/1 description: The image shows a logo for a company called "Sme". The logo consists of a stylized letter "S" made up of blue triangles, along with the text "Sme" in a gray sans-serif font. Below the text "Sme" is the text "MEDICAL TECH" in a smaller font size.
Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016 , Taiwan TEL:+886 (02) 2298 9578 FAX:+886 (02) 2298 9426
Section 5 : 510(k) Summary 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 12th, 2023
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 | Shanghai Apolo Medical Technology Co., Ltd. |
|---|---|
| Trade Name: | IPL Treatment Systems |
| 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: | K200746 May 15th, 2020 |
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
4
Image /page/4/Picture/1 description: The image contains a logo for Smedtrum Medical Technology Co., Ltd. The logo features a stylized "S" shape formed by overlapping blue and teal triangles, with a gray shadow extending from the left side. To the right of the symbol 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.
Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016 , Taiwan TEL:+886 (02) 2298 9578 FAX:+886 (02) 2298 9426
skin tissue's selective absorption.
| Spectra | Application areas | Expected Working Life |
|---|---|---|
| 420-1200nm | Vascular, acne, pigmentation | 100,000 shots |
| 510-1200nm | Vascular, pigmentation | 80,000 shots |
| 560-1200nm | Vascular, pigmentation | 70,000 shots |
| 610-1200nm | 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
(K200746) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Intense Pulsed Light System | IPL Treatment Systems |
| 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
(K200746) |
| Indication 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. | The IPL treatment systems is
intended for medical use in the
treatment of the following
dermatologic conditions:
-
Permanent hair reduction- long-
term stable reduction in number
of hairs re-growing after a
treatment regimen; -
Moderate inflammatory acne
vulgaris; -
Benign pigmented epidermal
lesions including dyschromia,
hyperpigmentation, melasma,
ephelides (freckles); -
Cutaneous lesions including
scars; -
Benign cutaneous vascular lesions
including port wine stains,
hemangiomas, facial truncal and
leg telangiectasias, erythema of
rosacea, leg veins, spider
angiomas and venous
malformations. |
| Light Source | Intense Pulsed light (Xenon
Flash Lamp) | Intense Pulsed light (Xenon Flash
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; | 420 -1200nm: Acne;
510 -1200nm: Acne, vascular,
pigment;
560 -1200nm: Acne, vascular,
pigment;
610-1200nm: Hair removal;
640-1200nm: Hair removal;
690-1200nm: Hair removal: |
| Feature | Proposed device | Predicate device
(K200746) |
| 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: 4.1-50.8 J/cm2;
510 -1200nm: 3.8-47 J/cm2
560 -1200nm: 3.7-43.3 J/cm2
610-1200nm: 3.5-38.7 J/cm2
640-1200nm: 3.3-37.4 J/cm2
690-1200nm: 3.1-33.4 J/cm2 |
| Pulsed Energy
density | 4.1-35 J/cm2 (1050 Level) | 4.1-50.8 J/cm2 |20 ms | 5
| Pulsed width | 520 ms |50 ms | 5~50 ms |
| Pulsed
duration | 5
| 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 |
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巨興醫學科技股份有限公司
Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016 , Taiwan
TEL:+886 (02) 2298 9578 FAX:+886 (02) 2298 9426
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Image /page/6/Picture/1 description: The image contains a logo for Smedtrum Medical Technology Co., Ltd. The logo features an abstract geometric shape in shades of teal and gray on the left side. To the right of the shape, the text "Smedtrum" is displayed in a stylized font, with the "S" in gray and the rest of the letters in teal. Below "Smedtrum", the words "MEDICAL TECHNOLOGY CO., LTD." are written in smaller, gray font.
Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016 , Taiwan TEL:+886 (02) 2298 9578 FAX:+886 (02) 2298 9426
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
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance
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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 geometric design in shades of teal and gray on the left side. To the right of the design is the company name, "Smedtrum" in a stylized font, with "MEDICAL TECHNOLOGY CO., LTD." printed in smaller letters below.
for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern since a failure of the software could result in minor injury to a patient or to a user of the device.
Sterilization and Shelf-Life
The proposed device is not provided sterile and does not need to be sterilized. The handpiece and the body are cleaned with a soft cloth moistened with ethanol of 70% strength or higher. The proposed device is reusable and does not have a restricted shelflife.
Biocompatibility
The handpiece sapphire tip may be contact with the intact skin of patients. According to FDA guidance document "Use of International Standard ISO 10993-1, " Biological evaluation of medical device - Part 1: Evaluation and testing within a risk management process "" three biological effects were determined in following three test: Cytotoxicity, Sensitization and Irritation.
In Cytotoxicity test, to determine the potential cytotoxicity of finished components, L-929 cell cultured in 96-well plates were treated with extract of 2 test article group:
Test article group 1: Test article extract, original extract
Test article group 2: 50% extract of the test article
The test results showed that the cell morphological grading of test group is the same as negative control group. The cell viability represented 100%, 93%, 11%, 74% and 96%; the mortality showed 0%, 7%, 89%, 26% and 4%. Under the conditions of this test, the extract of test article passed test requirement and did not show potential cytotoxicity to mouse fibroblast L-929 cells.
In Skin sensitization test. Guinea Pig Maximization Test (GPMT) were performed for determination of the skin sensitizing potential of test article extraction. The appearance of the challenge skin sites of the test and control animals 24 h and 48 h after removal of the patch was scored by grade of the skin reactions for erythema and oedema according to the Magnusson and Kligman grading scale. Under GPMT method, the results shows the test article did not cause delayed dermal contact sensitization in the guinea pig.
In Skin irritation test. The results showed that there were no erythema and edema findings in either the control or treatment group, and there were no mortalities. Furthermore, the PII values were 0 (Non-irritant). Therefore, a single topical
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Image /page/8/Picture/1 description: The image contains a logo with a geometric design on the left and text on the right. The geometric design consists of overlapping triangles in shades of blue and gray. To the right of the logo, there is text in Chinese characters, followed by the word "Smedtru" in a combination of gray and blue letters. Below "Smedtru", the words "MEDICAL TECHNOLOGY CO." are written in gray.
application of 0.5 ml of the test article extracts (Polar and non-polar groups) did not cause skin irritation.
Three biological effects, cytotoxicity, sensitization and irritation testing, were performed and test results did not identify any biological response or risk. The Intense Pulsed Light System meets the ISO 10993-1 standard requirements for biocompatibility and no further characterization testing is required.
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.
VII. CONCLUSION
The Intense Pulsed Light System has the same intended use, similar 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. 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.