(75 days)
Not Found
No
The description focuses on the physical principles of Intense Pulsed Light (IPL) and its application for aesthetic procedures. There is no mention of AI, ML, image processing, or data-driven decision-making within the device's operation. The performance studies are based on non-clinical testing against standards, not on the performance of an algorithm.
No
The device is indicated for permanent hair removal, reduction of benign pigmented lesions, and benign vascular lesions, which are generally considered aesthetic or cosmetic applications, not therapeutic. While some medical devices have dual therapeutic and aesthetic purposes, the stated indications prioritize cosmetic outcome (hair removal, lesion reduction) rather than treating a disease or medical condition.
No
The device is indicated for permanent hair removal and the reduction of benign pigmented and vascular lesions, which are therapeutic and aesthetic applications, not diagnostic.
No
The device description explicitly states it is an "intense pulsed light system" and includes a "handpiece used to deliver pulsed-light energy," indicating it is a hardware device that delivers energy.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions, and benign vascular lesions. These are all procedures performed directly on the patient's body.
- Device Description: The device is an intense pulsed light system that delivers light energy to the body.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not interact with or analyze any biological specimens.
The device described is a therapeutic and aesthetic medical device that applies energy directly to the patient.
N/A
Intended Use / Indications for Use
The Multi-modality workstation (inclusive of the handpiece used to deliver pulsed-light energy) 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.
Product codes (comma separated list FDA assigned to the subject device)
ONF
Device Description
The Multi-modality workstation is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 520mm. 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.
Based on this, the Multi-modality workstation (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in permanent hair removal, and reduction of benign pigmented lesions and benign vascular lesions.
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 (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 to support that it is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device conforms to the following standards:
a) IEC60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
b) AAMI/ANSI/ES 60601-1:2005/A1:2012, Medical 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) IEC 62471 First edition 2006-07, Photobiological safety of lamps and lamp systems
e) ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity. f) 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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 27, 2019
Beijing Superlaser Technology Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District BeiJing, 102401 CN
Re: K192519
Trade/Device Name: Multi-modality workstation, Model: AAD Dual Light 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: September 9, 2019 Received: September 13, 2019
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,
Purva Pandya 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) K192519
Device Name
Multi-modality workstation, Model: AAD Dual Light
Type of Use (Select one or both, as applicable)
Indications for Use (Describe)
The Multi-modality workstation (inclusive of the handpiece used to deliver pulsed-light energy) 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.
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|
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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: K192519
-
- Date of Preparation: 11/27/2019
-
- Sponsor Identification
Beijing Superlaser Technology Co., Ltd.
No.2 Zhongfu Street, Economic and Technological Industrial Zone, Xihongmen Town, Daxing District, Beijing, 100076, China
Contact Person: Shi Shuang Position: Registration Specialist Tel: +86-10-81284899 ext. 806 Fax: +86-10-81284899 Email: 672257488@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, China 102401
Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com
4
4. Identification of Proposed Device
Trade Name: Multi-modality workstation
Common Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect Model(s): AAD Dual Light
Regulatory Information:
Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology; Classification: II;
Product Code: ONF;
Regulation Number: 21 CFR 878.4810;
Review Panel: General & Plastic Surgery;
Indication For Use Statement:
The Multi-modality workstation (inclusive of the handpiece used to deliver pulsed-light energy) 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 Multi-modality workstation is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 520mm. 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.
Based on this, the Multi-modality workstation (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in permanent hair removal, and reduction of benign pigmented lesions and benign vascular lesions.
5. Identification of Predicate Device(s)
510(k) Number: K161286 Predicate Device Name: IPL Therapy Machine Manufacturer: Beijing ADSS Development Co., Ltd
5
6. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications to support that it is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device conforms to the following standards:
a) IEC60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
b) AAMI/ANSI/ES 60601-1:2005/A1:2012, Medical 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) IEC 62471 First edition 2006-07, Photobiological safety of lamps and lamp systems
e) ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity. f) ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity.
- Clinical Test Conclusion 7.
No clinical study is included in this submission.
6
Substantially Equivalent (SE) Comparison 8.
| ITEM | Proposed Device | Predicate Device
IPL Therapy Machine VE2000
(K161286) | Remark |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | ONF | ONF | SAME |
| Regulation
No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Class | II | II | SAME |
| Intended Use | The Multi-modality
workstation (inclusive of the
handpiece used to deliver
pulsed-light energy) 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. | The VE2000 device is indicated
for use in surgical, aesthetic
applications in permanent hair
reduction, 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. | SAME |
| Table 9-1 General Comparison |
|---|
| ------------------------------ |
7
| ITEM | Proposed Device | Predicate Device
IPL Therapy Machine VE2000
Systems(K161286) | Remark |
|----------------|--------------------------------------------------------------|--------------------------------------------------------------------|------------|
| Light source | Intense pulsed light | Intense pulsed light | SAME |
| Wavelength | 520-650;
800~1200;
540-800;
640-1200; | 480nm-1200nm
590nm-1200nm
640nm-1200nm | Analysis 1 |
| Deliver system | Sapphire | Sapphire | SAME |
| Energy density | 1-50J/cm2 | 1-50J/cm2 | SAME |
| Pulse Width | 1-25ms | 1-25ms | SAME |
| Max. Power | 3500VA | 2200W | Analysis 5 |
| Spot size | Small: 40 x 12 mm
Large: 46 x 16mm
Ex-Large: 60 x 20mm | 12x30mm | Analysis 1 |
Table 9-2 Performance Comparison
Table 9-3 Setting Comparison of Specified Indication for Use
| ITEM | Proposed Device | Predicate Device
IPL Therapy Machine VE2000
(K161286) | Remark |
|--------------------------|--------------------------------------------------------------|-------------------------------------------------------------|------------|
| hair removal | | | |
| Wavelength Range
(nm) | 640-1200 | 640-1200 | SAME |
| Energy Range
(J/cm2) | 5 to 40 | 10-44 | SIMILAR |
| Pulse Width (ms) | 1-25 | 3-14 | Analysis 3 |
| Spot Size (mm) | Small: 40 x 12 mm
Large: 46 x 16mm
Ex-Large: 60 x 20mm | 12x30mm | Analysis 4 |
| pigmented lesions | | | |
| Wavelength Range
(nm) | 540-800 | 480-1200 | Analysis 1 |
| Energy Range
(J/cm2) | 1-30 | 12-44 | Analysis 2 |
| Pulse Width (ms) | 1-20 | 3-9 | Analysis 3 |
| Spot Size (mm) | 40 x 12 mm | 12x30mm | Analysis 4 |
| vascular lesions | | | |
| Wavelength Range
(nm) | 520-650;
800-1200 | 590-1200 | Analysis 1 |
| Energy Range
(J/cm2) | 5-30 | 10-42 | Analysis 2 |
8
| (J/cm2) | |||
|---|---|---|---|
| Pulse Width (ms) | 1-15 | 3-8 | Analysis 3 |
| Spot Size (mm) | 40 x 12 mm | 12x30mm | Analysis 4 |
Difference Analysis:
#1: Wavelength
The wavelength range of proposed devices is very closed to that of predicate devices. The slight difference is considered to have no negative effect on effectiveness and safety, and the bench tests conducted on the proposed device support substantial equivalence to the predicate device.
#2: Energy Range
The proposed device has an energy output range that is similar to the predicate device, and the slight differences do not result in negative safety and efficacy effects. The bench tests conducted on the proposed device support substantial equivalence to the predicate device.
#3: Pulse Width
The proposed device has a similar pulse width range as the predicate device. The slight difference in settings do not result in negative safety and effectiveness. The bench tests conducted on the proposed device support substantial equivalence to the predicate device.
#4: Spot Size
The proposed device has different spot size with the predicate device. However the differences in spot sizes are not considered to produce a negative effect on safety. The bench tests conducted on the proposed device support substantial equivalence to the predicate device.
#5 Max Power
The maximum input power of the proposed device is different from the predicate device. However, the proposed device conforms to IEC 60601-1 and IEC 60601-1-2 regarding device safety and electromagnetic compatibility
| ITEM | Proposed Device | Predicate Device
IPL Therapy Machine VE2000
(K161286) | Remark |
|----------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------|
| | | | |
| | | | |
| Power supply | 110V, 60Hz or 230V, 50Hz | 110V 50Hz | Analysis 6 |
| 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 |
Table 9-4 Safety Comparison
9
| Patient Contact
| Material | Handpiece | Handpiece | 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 |
#6 Power Supply
The power supply of the proposed device is different from the predicate device. However, the proposed device conforms to IEC 60601-1 and IEC 60601-1-2 regarding device safety and electromagnetic compatibility.
9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.