(90 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on combining different laser and light technologies without mentioning any AI/ML capabilities.
Yes
The device description explicitly states, "The BL-M10 is a new platform treatment system... that uses multiple therapeutic modalities in combination or in isolative and non-ablative treatment of skin surface." The 'Intended Use / Indications for Use' section lists numerous dermatologic conditions and procedures, such as permanent hair reduction, treatment of inflammatory acne vulgaris, benign pigmented lesions, vascular lesions, tattoo removal, and skin resurfacing, all of which are therapeutic in nature.
No
The device description and intended use section clearly state that this device is a "treatment system" utilizing various laser and light technologies for dermatologic conditions and surgical procedures, such as hair reduction, acne treatment, lesion removal, and tattoo removal. There is no mention of it being used for diagnosis or detection.
No
The device description explicitly states it is a "platform treatment system" that is "AC-powered" and "mobile (on wheels)" and includes "various energy sources and dedicated hand-pieces." This indicates a physical hardware device, not software only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended uses listed for all the different modalities (IPL, Diode Laser, Triple Diode Laser, Picosecond Nd:YAG Laser, 1064nm Long pulse Nd:YAG, Q-switch Nd:YAG laser) are all related to treating various dermatologic conditions and performing surgical/aesthetic procedures on the skin. This involves direct interaction with the patient's body for therapeutic purposes.
- Device Description: The device description confirms it's a platform system with different handpieces designed to apply energy to the skin for treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVDs are used to perform tests outside the body on samples taken from the body. This device is clearly designed for direct therapeutic application on the body.
N/A
Intended Use / Indications for Use
(1) IPL: The Therapy IPL is intended for medical use in the following dermatologic conditions: Permanent hair reduction- long-terms table reduction in number of hairs re-growing after a treatment - 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.
(2) Diode laser: Diode laser treatment handset is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. It is suitable for all skin type I-VI), including tanned skin. 3) Triple Diode laser: The device is intended for use in dermatologic and general surgical procedures.
The Triple diode laser Module is intended for use in dermatology procedures requiring coagulation. The Triple diode laser Module is indicated for: - Benign vascular and vascular dependent lesions removal.
(4) Picosecond Nd: Y AG Laser: The Picosecond Nd: Y AG Laser is intended for use in surgical and aestheir applications in the medical specialties of dermatology and general and plastic surgery. - The 1064nm wavelength of the Picosecond Nd:YAG Laser is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI). - The 532mm wavelength of the Picosecond Nd: Y AG Laser is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types 1-III.
(5) 1064nm Long pulse Nd: YAG: The 1064nm Long pulse Nd: YAG is indicated for - Benign vascular lesions. -
Superficial and deep telangiectasias). - Benign cutaneous lesions. - Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. - The non-ablative treatment of facial wrinkles. - Laser skin resurfacing procedures. - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. - Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. - Removal or lightening of unwanted hair (with and without adjuvant preparation). - Treatment of pseudofolliculitis barbae (PFB).
(6) Q-switch Nd:YAG laser: The Q-switch Nd:YAG Laseris Module indicated for: -Benign vascular and pigmented lesions, age spots. - Nevus spilus. - Tattoo removal.
Product codes (comma separated list FDA assigned to the subject device)
GEX, ONF
Device Description
The BL-M10 is a new platform treatment system with 12.1" display screen which combines IPL/ Diode Laser/Triple Diode Laser/ Picosecond Nd:YAG Laser/ 1064nm Long pulse Nd:YAG laser and Q-switch Nd:YAG Laser functions. This is 6 in 1 platform machine, that provides different function with attaching different hand pieces. The system is designed with a mains electricity (AC-powered) mobile (on wheels) assembly of devices that uses multiple therapeutic modalities in combination or in isolative and non-ablative treatment of skin surface. The system includes various energy sources and dedicated hand-pieces intended to apply the different energies to the skin for respective indications for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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)
VII.1. Non-Clinical Testing: A battery of tests was performed to verify that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards: Electrical safety and electromagnetic compatibility
- A 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 60601-1-2:2014 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-2-22:2007+A1: 2012 Medical electrical equipment Part 2-22: Particular A requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- A IEC 60825-1:2014 Safety of Laser products-Part 1: Equipment classification and requirements
- A IEC 62471:2006 Photobiological safety of lamps and lamp systems
- IEC 60601-2-57:2011 Medical electrical equipment Part 2-57: Particular requirements A for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.
Non-Clinical testing of the Multi-Function Platform Systems (BL-M10) was conducted to assess the safety and performance characteristics of the device's multiple handpieces. These tests were designed to demonstrate compliance with established standards and to support claims of substantial equivalence to the respective predicate devices.
Test Categories and Results:
- Electrical Safety and Electromagnetic Compatibility
- Compliance with IEC 60601-1 for basic safety and essential performance.
- Testing per IEC 60601-1-2 for electromagnetic compatibility demonstrated that the BL-M10 does not emit harmful interference and is immune to typical electromagnetic disturbances in its intended environments.
VII.2. Performance Testing
- Each handpiece underwent rigorous performance testing to verify adherence to specified energy output, wavelength accuracy, pulse duration, and spot size.
- The testing confirmed that all handpieces meet or exceed the performance characteristics of their predicate devices.
VII.3. Laser and Light Safety
- Tests conducted under IEC 60601-2-22 for laser safety and IEC 62471 for photobiological safety, ensuring that both patient and operator are protected from potential hazards of laser and light exposure.
- The device's safety features, such as emergency shut-off and controlled access mechanisms, were verified to function correctly under all tested conditions.
VIII. Clinical Testing
Not Applicable.
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.
K200746, K200118, K172193, K233018, K203395, K192856
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 for 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. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
May 20, 2024
Shanghai Bele Medical Technology Co., Ltd Jeremy Li Room 402, 4F, Building 1, NO.3255 Shengang Road, Songjiang District Shanghai, Shanghai 201600 China
Re: K240474
Trade/Device Name: Multi-function Platform Systems (BL-M10) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX, ONF Dated: April 30, 2024 Received: April 30, 2024
Dear Jeremy Li:
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.
1
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).
2
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. Hithe -S Date: 2024 05 20 15.18.25 -04'00
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical & Infection Control Devices, Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240474
Device Name Multi-function Platform Systems (BL-M10)
Indications for Use (Describe)
(1) IPL: The Therapy IPL is intended for medical use in the following dermatologic conditions: Permanent hair reduction- long-terms table reduction in number of hairs re-growing after a treatment - 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.
(2) Diode laser: Diode laser treatment handset is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. It is suitable for all skin type I-VI), including tanned skin. 3) Triple Diode laser: The device is intended for use in dermatologic and general surgical procedures.
The Triple diode laser Module is intended for use in dermatology procedures requiring coagulation. The Triple diode laser Module is indicated for: - Benign vascular and vascular dependent lesions removal.
(4) Picosecond Nd: Y AG Laser: The Picosecond Nd: Y AG Laser is intended for use in surgical and aestheir applications in the medical specialties of dermatology and general and plastic surgery. - The 1064nm wavelength of the Picosecond Nd:YAG Laser is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI). - The 532mm wavelength of the Picosecond Nd: Y AG Laser is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types 1-III.
(5) 1064nm Long pulse Nd: YAG: The 1064nm Long pulse Nd: YAG is indicated for - Benign vascular lesions. -
Superficial and deep telangiectasias). - Benign cutaneous lesions. - Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. - The non-ablative treatment of facial wrinkles. - Laser skin resurfacing procedures. - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. - Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. - Removal or lightening of unwanted hair (with and without adjuvant preparation). - Treatment of pseudofolliculitis barbae (PFB).
(6) Q-switch Nd:YAG laser: The Q-switch Nd:YAG Laseris Module indicated for: -Benign vascular and pigmented lesions, age spots. - Nevus spilus. - Tattoo removal.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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5
l. Submission Submission Number K240474 Device submitter Shanghai Bele Medical Technology Co. Ltd. Room 402, 4F, Building 1, NO.3255 Shengang Road, Songjiang District, Shanghai, China Contact Person Jeremy Li +86-21 51012882 Phone Number Email jeremy@belemed.com Submission Date May 16, 2024 II. Device Information Trade Name Multi-function Platform Systems (BL-M10) Laser surgical instrument for use in general and plastic surgery Common Name and in dermatology Classification Name Powered Laser Surgical Instrument Regulation Number 21 CFR 878.4810 Product Code GEX, ONF
III. Predicate Devices
| Trade Name of Device: | IPL Treatment System |
|---|---|
| Common name: | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology | |
| Classification: | Class II, 21 CFR 878.4810. |
| Product Code: | ONF |
| Premarket Notification: | K200746 |
| Company name: | Shanghai Apolo Medical Technology Co., Ltd. |
| Trade Name of Device: | Diode Laser Therapy Device |
|---|---|
| Common name: | Powered Laser Surgical Instrument |
| Classification: | Class II, 21 CFR 878.4810 |
| Product Code: | GEX |
| Premarket Notification: | K200118 |
| Company name: | Shanghai Apolo Medical Technology Co., Ltd. |
| Trade Name of Device: | Modified Alma Lasers Soprano XL™ Family ofMulti-
Application & MultiTechnology Platforms [SopranoXL,
SopranoXLi, SopranoICE and Soprano ICE Platinum] with
Duo and Trio Diode Laser Modules., Soprano Duo and Trio |
| ----------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
6
| Diode Laser Modules | |
|---|---|
| Common name: | Laser Powered Surgical Instruments (& Accessories) |
| Classification: | Class II, 21 CFR 878.4810. |
| Product Code: | GEX, ILY |
| Premarket Notification: | K172193 |
| Company name: | Alma Lasers Inc. |
| Trade Name of Device: | PICOSECOND Nd:YAG Laser System |
|---|---|
| Common name: | / |
| Classification: | Class II, 21 CFR 878.4810. |
| Product Code: | GEX |
| Premarket Notification: | K233018 |
| Company name: | IDS, Ltd. |
| Trade Name of Device: | Platform treatment system |
|---|---|
| Common name: | Powered Laser Surgical Instrument |
| Classification: | Class II, 21 CFR 878.4810. |
| Product Code: | ONF, GEX |
| Premarket Notification: | K203395 |
| Company name: | Shanghai Apolo Medical Technology Co., Ltd. |
| Trade Name of Device: | MT ONE |
|---|---|
| Common name: | Intense Pulsed Light(IPL) and laser System |
| Classification: | Class II, 21 CFR 878.4810. |
| Product Code: | GEX, ONG, ONF, ONE |
| Premarket Notification: | K192856 |
| Company name: | M&TS.R.L. |
IV. Device description
The BL-M10 is a new platform treatment system with 12.1" display screen which combines IPL/ Diode Laser/Triple Diode Laser/ Picosecond Nd:YAG Laser/ 1064nm Long pulse Nd:YAG laser and Q-switch Nd:YAG Laser functions. This is 6 in 1 platform machine, that provides different function with attaching different hand pieces. The system is designed with a mains electricity (AC-powered) mobile (on wheels) assembly of devices that uses multiple therapeutic modalities in combination or in isolative and non-ablative treatment of skin surface. The system includes various energy sources and dedicated hand-pieces intended to apply the different energies to the skin for respective indications for use.
K240474 Shanghai Bele Medical Technology Co.,Ltd.
7
V. Indications for use
- (1) IPL: The Therapy IPL is intended for medical use in the treatment of the following dermatologic conditions: - Permanent hair reduction- long-terms table reduction in number of hairs re-growing after a treatmen; - 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.
- (2) Diode laser: Diode laser treatment handpiece (808nm) handset is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. It is suitable for all skin types (Fitzpatrick skin type I-VI), including tanned skin.
- (3) Triple Diode laser: The device is intended for use in dermatologic and general surgical procedures. The Triple diode laser Module is intended for use in dermatology procedures requiring coagulation. The Triple diode laser Module is indicated for:
- Benign vascular and vascular dependent lesions removal.
- (4) Picosecond Nd:YAG Laser: The Picosecond Nd:YAG Laser is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. - The 1064nm wavelength of the Picosecond Nd:YAG Laser is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI). - The 532nm wavelength of the Picosecond Nd:YAG Laser is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.
- (5) 1064nm Long pulse Nd:YAG: Benign vascular lesions Superficial and deep telangiectasias (venulectasias) - Benign cutaneous lesions to reduce lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. - The non-ablative treatment of facial wrinkles. - Laser skin resurfacing procedures. - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. - Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. - Removal or lightening of unwanted hair (with and without adjuvant preparation). - Treatment of pseudofolliculitis barbae (PFB).
- (6) Q-switch Nd:YAG laser: The Q-switch Nd:YAG Laseris Module indicated for: Benign vascular and pigmented lesions, age spots • Nevus spilus • Tattoo removal
VI. Comparison of Technological Characteristics with Predicate Devices
The Multi-function Platform Systems (BL-M10) shares the same technological characteristics as its predicate devices, including energy sources (laser/IPL), control mechanisms, and core specifications.
8
| Tabel 1 Substantial equivalence discussion - IPL | ||
|---|---|---|
| Device feature | IPL (subject device) | IPULSELIGHT IPL SYSTEM K200746 (predicate device) | Discussion |
|---|---|---|---|
| Intended use | The Therapy IPL is | ||
| intended for medical use in | |||
| the treatment of the | |||
| following dermatologic | |||
| conditions: |
- Permanent hair reduction-
long-terms table 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. | The IPL treatment
systems is intended for
medical use in the
treatment of the following
dermatologic conditions: - Permanent hair
reduction- long-terms
table 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. | Identical |
| Light source | Intense pulsed light (Xenon
Flash Lamp) | Intense pulsed light
(Xenon Flash Lamp) | Identical |
| Wavelength | Filters: | Filters: | Identical |
| Device feature | IPL (subject device) | IPULSELIGHT IPL SYSTEM K200746
(predicate device) | Discussion |
| Range | 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; | 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; | |
| Handpiece
Ports | IPL treatment handpiece | HS-650K&HS-660K: 2
HS620K, HS-300CK &
HS-310K: 1 | Different 1 |
| Structure | Vertical | HS-650K&HS-660K:
Vertical
HS620K, HS-300CK &
HS-310K: Table top | Different 2 |
| Energy output | 10-50 J/cm² | 4.1-50.8 J/cm² | Different 3 |
| Pulse width | 2-20ms | 5-20 ms | Different 4 |
| Pulse duration | 5-50 ms | 5-50 ms | Identical |
| Spot size | 15mm×50mm | 1235mm, 1550mm | Different 5 |
| Output mode | Pulse mode | Pulse mode | Identical |
| Deliver
materials | Direct sapphire Coupling | Direct sapphire Coupling | Identical |
| Cooling method | Water cooling, forced-air
cooling and TEC water tank
cooling system and
semiconductor chip | HS-650K&HS-660K:
Water cooling, forced-air
cooling, copper and TEC;
HS620K,
HS-300CK&HS-310K:
Water cooling and forced-air cooling | Different 7 |
| - | Spot Size: | The subject device offers a spot size of 15mm×50mm, covered by the predicate | |
9
Conclusion:
Handpiece Ports: The subject device has one IPL treatment handpiece port, while the ।
10
predicate device offers multiple handpiece ports depending on the model. However, this difference in handpiece ports does not affect the intended use of the device, as both devices are capable of delivering the required treatments with their respective handpieces.
- Energy Output: The energy output ranges of both devices are within similar ranges, with the subject device ranging from 10-50 J/cm² and the predicate device ranging from 4.1-50.8 J/cm². While there is a difference in the upper limit of the energy output, both devices offer sufficient energy levels for effective treatment across various dermatologic conditions.
- Pulse Width: The subject device offers pulse widths ranging from 2-20ms, whereas the predicate device offers pulse widths ranging from 5-20 ms, which are basically similar. These differences in pulse parameters are minor and do not significantly impact the intended use of the devices for dermatologic treatments.
| Device feature | Diode Laser
(subject device) | Diode Laser Therapy
Device K200118
(predicate device) | Discussion |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Intended use | Diode laser treatment
(808nm) handpiece
handset is indicated for
permanent reduction in hair
regrowth defined as a long
term, stable reduction in
the number of hairs re-
growing when measured at
6,9 and 12 months after the
completion of a treatment
regimen. It is suitable for all
skin types (Fitzpatrick skin
type I-VI), including tanned
skin. | The Diode Laser Therapy
Device is indicated for
permanent reduction in
hair regrowth defined as a
long term, stable
reduction in the number of
hairs re-growing when
measured at 6,9 and 12
months after the
completion of a treatment
regimen. It is suitable for
all skin types (Fitzpatrick
skin type I-VI), including
tanned skin. | Identical |
| Spot Size | 12mm×23mm | 12x16mm;
12x20mm | Different 1 |
| Energy Source | 808nm diode laser | 755nm handpiece
810nm handpiece
1064nm handpiece | Different 2 |
| Wavelength | 808nm | 755nm/810nm/1064nm | Different 3 |
Tabel 2 Substantial equivalence discussion - Diode Laser
11
| Device feature | Diode Laser
(subject device) | Diode Laser Therapy
Device K200118
(predicate device) | Discussion |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| | | for option | |
| Maximum
Repetition Rate | 1,2,3,5,8,10Hz | 1,2,3,5,8,10Hz | Similar |
| Pulse Duration | 10-300ms | 10-300ms | Identical |
| Energy | 1-62J/cm² | 164J/cm262J/cm2 | Different 4 |
1
| Device feature | Triple Diode laser
(subject device) | Modified Alma Lasers
Soprano XL™ Family
ofMulti-Application &
MultiTechnology
Platforms [SopranoXL,
SopranoXLi,
SopranoICE and
Soprano ICE Platinum]
with Duo and Trio Diode
Laser Modules.,
Soprano Duo and Trio
Diode Laser Modules
K172193
(predicate device) | Discussion |
| Intended use | Intended Use
The device is intended for
use in dermatologic and
general surgical
procedures.
Indications for Use
The triple diode laser
Module is intended for use
in dermatology procedures
requiring coagulation. The
Triple diode laser Module is
indicated for:
● Benign vascular and
vascular dependent
lesions removal. | Intended Use
The device is intended for
use in dermatologic and
general surgical
procedures.
Indications for Use
The Soprano trio Diode
Laser Module is intended
for use in dermatology
procedures requiring
coagulation. The
indications for use for the
Soprano Trio Diode Laser
Module include:
● Benign vascular and
vascular dependent
lesions removal. | Identical |
| Spot Size | 12mm×23mm | Trio 4 cm² applicator
Trio 2 cm² applicator | Different 1 |
| Wavelength | 755/808/1064nm | 755/808/1064nm | Identical |
| Maximum
Repetition Rate | 110Hz | 1-10 Hz | Identical |32J/cm² | up to 60 J/cm² | Different 3 |
| Device feature | Triple Diode laser
(subject device) | Modified Alma Lasers
Soprano XL™ Family
ofMulti-Application &
MultiTechnology
Platforms [SopranoXL,
SopranoXLi,
SopranoICE and
Soprano ICE Platinum]
with Duo and Trio Diode
Laser Modules.,
Soprano Duo and Trio
Diode Laser Modules
K172193
(predicate device) | Discussion |
| Pulse Duration | 10-130ms | 3.3-280 ms | Different 2 |
| Energy | 1
Conclusion:
-
Different 1: ।
Spot Size: The subject device has a larger spot size (12mm×23mm) compared to the predicate device. A larger spot size can affect the treatment speed and efficiency, reducing treatment time. -
Different 2&3: -
Energy Source (Wavelength): Both the subject device and the HS-817 & HS-819 models of the predicate device operate with diode lasers in the 808nm to 810nm range. This slight difference in wavelength (808nm for the subject device vs. 810nm for the predicate models) is minimal and likely does not affect the efficacy or safety profiles of the devices significantly. Operating in a similar near-infrared spectrum, they are expected to have comparable penetration depths and effects on hair follicles, ensuring a similar mechanism of action for hair removal. -
Different 4
The subject device operates with an energy range of 1-62 J/cm², which is slightly lower than the maximum value of 64 J/cm² for one of the settings of the predicate device. This variation in maximum energy output may affect the ability of the device to adapt to different hair densities and skin types. A lower maximum energy may mean that the emphasis on comfort and minimising skin irritation is beneficial for sensitive skin types or for use on more delicate areas.
Both the subject and the predicate devices share the primary function of hair removal, employing diode lasers to achieve this end. Despite minor variations in their specifications, such as energy output and spot size, the core technology remains consistent, suggesting a substantial equivalence in therapeutic outcome. Therefore, the differences identified do not raise concerns regarding the intended use or safety of the subject device.
12
Tabel 3 Substantial equivalence discussion - Triple Diode laser
13
Conclusion:
-
Different 1: -
Spot Size: The subject device's spot size of 12mm×23mm (2.76cm²) is different from the predicate device's options of 4cm² and 2cm², but is within the range of the predicate device. -
Different 2: -
Pulse Duration: The subject device offers pulse duration within the range covered by the predicate. -
Different 3:
Energy: The subject device offers energy level covered by the predicate.
In conclusion, the differences in some parameters between the subject device and the predicate device are minor. The core technology and operational principles remain consistent, ensuring that the subject device is substantially equivalent to the predicate device.
Tabel 4 Substantial equivalence discussion - Picosecond Nd:YAG Laser
| Device feature | Picosecond Nd:YAG
Laser (subject device) | PICOSECOND Nd: YAG
Laser System K233018
(predicate device) | Discussion |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Intended use | The Picosecond Nd:YAG
Laser is intended for use in | The PICOSECOND Nd:
YAG Laser System (PICO | Identical |
| Device feature | Picosecond Nd:YAG
Laser (subject device) | PICOSECOND Nd: YAG
Laser System K233018
(predicate device) | Discussion |
| | surgical and aesthetic
applications in the medical
specialties of dermatology
and general and plastic
surgery.
- The 1064nm wavelength
of the Picosecond Nd:YAG
Laser is indicated for tattoo
removal for dark-colored
tattoo inks and multicolored
tattoos containing dark-
colored tattoo inks on
patients with all skin types
(Fitzpatrick I-VI). - The 532nm wavelength of
the Picosecond Nd:YAG
Laser is indicated for tattoo
removal for lighter-colored
tattoo inks, including red
and yellow inks, on patients
with Fitzpatrick skin types I-
III. | PREMIUM) is intended for
use in surgical and
aesthetic applications
in the medical
specialties of
dermatology and general
and plastic surgery. - The 1064nm wavelength
of the PICOSECOND Nd:
YAG Laser System (PICO
PREMIUM) is indicated
for tattoo removal for
dark-colored tattoo inks
and multicolored
tattoos containing
dark-colored tattoo
inks on patients with all
skin types (Fitzpatrick I-
VI). - The 532nm wavelength
of the PICOSECOND Nd:
YAG Laser System (PICO
PREMIUM) is indicated
for tattoo removal for
lighter-colored tattoo
inks, including red
and yellow inks, on
patients with
Fitzpatrick skin types I-III. | |
| Spot Size | 1, 2, 3, 4, 5, 7 mm | 2mm - 10mm (Adjustable
by 1mm) - Both Modes | Different 1 |
| Wavelength | Double wavelength | 532 or 1064nm (+/-10%) | Identical |
| Device feature | Picosecond Nd:YAG Laser (subject device) | PICOSECOND Nd: YAG Laser System K233018 (predicate device) | Discussion |
| | 1064nm&532nm | | |
| Maximum Repetition Rate | 1-10Hz | 1-10Hz (Adjustable by 1Hz) | Identical |
| Pulse Duration | IEC 60601-1-2:2014 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests - IEC 60601-2-22:2007+A1: 2012 Medical electrical equipment Part 2-22: Particular A requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- A IEC 60825-1:2014 Safety of Laser products-Part 1: Equipment classification and requirements
- A IEC 62471:2006 Photobiological safety of lamps and lamp systems
- IEC 60601-2-57:2011 Medical electrical equipment Part 2-57: Particular requirements A for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.
Non-Clinical testing of the Multi-Function Platform Systems (BL-M10) was conducted to assess the safety and performance characteristics of the device's multiple handpieces. These tests were designed to demonstrate compliance with established standards and to support claims of substantial equivalence to the respective predicate devices.
Test Categories and Results:
- Electrical Safety and Electromagnetic Compatibility
- Compliance with IEC 60601-1 for basic safety and essential performance.
- Testing per IEC 60601-1-2 for electromagnetic compatibility demonstrated that the BL-M10 does not emit harmful interference and is immune to typical electromagnetic disturbances in its intended environments.
VII.2. Performance Testing
-
Each handpiece underwent rigorous performance testing to verify adherence to specified energy output, wavelength accuracy, pulse duration, and spot size.
-
The testing confirmed that all handpieces meet or exceed the performance characteristics of their predicate devices.
19
VII.3. Laser and Light Safety
-
Tests conducted under IEC 60601-2-22 for laser safety and IEC 62471 for photobiological safety, ensuring that both patient and operator are protected from potential hazards of laser and light exposure.
-
The device's safety features, such as emergency shut-off and controlled access mechanisms, were verified to function correctly under all tested conditions.
VIII. Clinical Testing
Not Applicable.
IX. Conclusion
Based on the comparison and substantial equivalence discussion provided, the Multi-function Platform Systems (BL-M10) is substantially equivalent to its predicate devices. The differences identified do not raise concerns regarding the intended use or safety of the subject device. The core technology and operational principles remain consistent, ensuring effective and safe treatment outcomes.