(28 days)
Not Found
No
The summary describes a standard IPL system based on selective thermolysis principles and does not mention any AI or ML components, image processing, or data-driven features.
Yes
The device is indicated for permanent hair removal and reduction of benign pigmented and vascular lesions, which are generally considered therapeutic in nature as they address a medical or cosmetic condition. Additionally, one of the compliance standards (IEC60601-2-57:2011) explicitly mentions "therapeutic...use."
No
The device is described as an Intense Pulsed Light Treatment System used for "surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions." Its function is therapeutic/cosmetic, not diagnostic.
No
The device description clearly states it is an "intense pulsed light system" which delivers light at specific wavelengths, indicating it is a hardware device that emits light for treatment. The performance studies also reference standards related to electrical equipment and biological evaluation, further supporting it as a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical and aesthetic applications on the human body (permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions). This involves direct interaction with the patient's tissues.
- Device Description: The device is an Intense Pulsed Light (IPL) system that delivers light to the body for therapeutic purposes.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. This device does not perform tests on samples taken from the body.
The device is a therapeutic device that applies energy to the body for treatment, not a diagnostic device that analyzes samples.
N/A
Intended Use / Indications for Use
The Intense Pulsed Light Treatment System (Model: HM-IPL-B8) are indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Product codes (comma separated list FDA assigned to the subject device)
ONF
Device Description
The EROSE-YA device is an intense pulsed light system which delivers intense pulsed light at wavelengths ranging from 430mm-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.
IPL systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intense Pulsed Light
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgical and aesthetic applications
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
a) IEC 60601-1-2 :2014/AMD1:2020. Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
b) IEC 60601-1:2005+A1:2012+A2:2020, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
c) IEC60601-2-57:2011. 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
d) ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity.
e) ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity.
No clinical study is included in this submission.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 21, 2023
Shangdong Huamei Technology Co., Ltd. % Ray Wang General Manger Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, 102401 China
Re: K230816
Trade/Device Name: Intense Pulsed Light Treatment 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: March 23, 2023 Received: March 24, 2023
Dear Ray Wang:
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
1
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 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
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
Submission Number (if known)
Device Name
Intense Pulsed Light Treatment System (EROSE-YA)
ndications for Use (Describe)
The Intense Pulsed Light Treatment System (Model: HM-IPL-B8) are indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of 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)
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
510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K230816
-
- Date of Preparation: 03/23/2023
-
- Sponsor Identification
Shangdong Huamei Technology Co., Ltd.
No. 588, Changning Street, High-tech District, WeiFang, ShanDong, China, 261205
Contact Person: Yugui Dong Position: Vice-general manager Tel: +86-15306469955 Email: 2851353667@qq.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing City, China, 102401 Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com
4
4. Identification of Proposed Device
Trade Name: Intense Pulsed Light Treatment System Common Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect Model(s): EROSE-YA
Regulatory Information:
Classification Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect Classification: II; Product Code: ONF; Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery;
Indication For Use Statement:
The Intense Pulsed Light Treatment System (Model: EROSE-YA)) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Device Description:
The EROSE-YA device is an intense pulsed light system which delivers intense pulsed light at wavelengths ranging from 430mm-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.
IPL systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores.
- న. Identification of Predicate Device(s)
510(k) Number K192521
Predicate Device Name Intense Pulsed Light Treatment System
Manufacturer Shangdong Huamei Technology Co., Ltd.
Intended Use:
5
The Intense Pulsed Light Treatment System (Model: HM-IPL-B8) are indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
a) IEC 60601-1-2 :2014/AMD1:2020. Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
b) IEC 60601-1:2005+A1:2012+A2:2020, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
c) IEC60601-2-57:2011. 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
d) ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity.
e) ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity.
7. Clinical Test Conclusion
No clinical study is included in this submission.
6
| Predicate Device | |||
|---|---|---|---|
| ITEM | Proposed Device | Intense Pulsed Light Treatment | |
| System (K192521) | Remark | ||
| Product Code | ONF | ONF | SE |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Class | II | II | SE |
| Intended Use | The Intense Pulsed Light Treatment System (Model: HM-IPL-B8) are indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions. | ||
| Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. | The Intense Pulsed Light Treatment System (Model: HM-IPL-B8) are indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions. | ||
| Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. | SE |
Substantially Equivalent (SE) Comparison 8.
| Table 1 General Comparison | |||
|---|---|---|---|
| -- | ---------------------------- | -- | -- |
Table 2 Performance Comparison
| ITEM | Proposed Device | Predicate Device
Intense Pulsed Light Treatment
System (K192521) | Remark |
|----------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|--------|
| Light source | Intense pulsed light | Intense pulsed light | SE |
| Wavelength | $430-1200nm , 530-1200nm ,640-1200nmOptional : 480nm-1200nm ,560-1200nm, 590-1200nm,690-1200nm, 750nm-1200nm$ | $430-1200nm , 530-1200nm ,640-1200nmOptional : 480nm-1200nm ,560-1200nm, 590-1200nm,690-1200nm, 750nm-1200nm$ | SE |
| Deliver system | Sapphire | Sapphire | SE |
| Energy density | $10-50J/cm2 ±20%error$ | $10-50J/cm2$ | SE |
| Pulse Delay | $5-50ms ±10%error$ | $5-50ms$ | SE |
| Pulse Width | $1-20ms ±10%error$ | $1-20ms$ | SE |
| Max. Power | $2000W$ | $2000W$ | SE |
| Spot size | $15mm×50mm; 80mm×40mm±20%error$ | $15mm×50mm; 80mm×40mm$ | SE |
7
| ITEM | Proposed Device | Predicate Device
Intense Pulsed Light Treatment
System (K192521) | Remark |
|---------------------------------|--------------------------------|------------------------------------------------------------------------|--------|
| permanent hair reduction | | | |
| Wavelength Range
(nm) | 640-1200/690-1200/ 750-1200 | 640-1200/690-1200/ 750-1200 | |
| Energy Range
(J/cm2) | 10-44 | 10-44 | SE |
| Pulse Width (ms) | 3-14 | 3-14 | |
| Pulse Delay (ms) | 16-32 | 16-32 | |
| Spot Size (mm) | 15mm×50mm; 80mm×40mm; | 15mm×50mm; 80mm×40mm; | |
| pigmented lesions | | | |
| Wavelength Range
(nm) | 480-1200/530-1200/560-1200 | 480-1200/530-1200/560-1200 | |
| Energy Range
(J/cm2) | 12-44 | 12-44 | SE |
| Pulse Width (ms) | 3-9 | 3-9 | |
| Pulse Delay (ms) | 16-32 | 16-32 | |
| Spot Size (mm) | 15mm×50mm; 80mm×40mm; | 15mm×50mm; 80mm×40mm; | |
| vascular lesions | | | |
| Wavelength Range
(nm) | 530-1200/560-1200/
590-1200 | 530-1200/560-1200/
590-1200 | |
| Energy Range
(J/cm2) | 10-42 | 10-42 | SE |
| Pulse Width (ms) | 3-8 | 3-8 | |
| Pulse Delay (ms) | 16-32 | 16-32 | |
| Spot Size (mm) | 15mm×50mm; 80mm×40mm; | 15mm×50mm; 80mm×40mm; | |
Table 3 Setting Comparison of Specified Indication for Use
8
| ITEM | Proposed Device
EROSE-YA | Predicate Device
Intense Pulsed Light Treatment
System (K192521) | Remark |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------|
| Power supply | $110V \pm 10%$ 60Hz | $110V \pm 10%$ 60Hz | SE |
| Electrical
Safety | The proposed devices were tested
to demonstrated to comply with
IEC 60601-1 | The proposed devices were tested
to demonstrated to comply with
IEC 60601-1 | SE |
| EMC | The proposed devices were tested
to demonstrated to comply with
IEC 60601-1-2 | The proposed devices were tested
to demonstrated to comply with
IEC 60601-1-2 | SE |
| Patient Contact
Material | Handpiece (Sapphire Crystal) | Handpiece (Sapphire Crystal) | SE |
| Biocompatibility | | | |
| Cytotoxicity | No toxicity (ISO 10993-5) | No toxicity (ISO 10993-5) | SE |
| Irritation | Applied sample did not induce
irritation to skin. (ISO 10993 -10) | Applied sample did not induce
irritation to skin. (ISO 10993 -10) | SE |
| Sensitization | The test article showed no
signification evidence of causing
skin sensitization in the guinea
pig .(ISO 10993-10) | The test article showed no
signification evidence of causing
skin sensitization in the guinea
pig .(ISO 10993-10) | SE |
Table 4 Safety Comparison
-
- Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
- Substantially Equivalent (SE) Conclusion