(77 days)
No
The device description and performance studies focus on the physical properties of light emission and electrical safety, with no mention of AI or ML algorithms for analysis, control, or decision-making.
Yes
The device is described as "Photon therapy apparatus use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions," and also states its use for "the temporary relief of minor muscle and joint pain, atthritis and muscle spasm" among other medical conditions. The term "treat" directly indicates a therapeutic purpose.
No
The device's intended use and stated functions are solely for therapeutic purposes (treating dermatological conditions, pain relief, circulation) by emitting light, not for identifying or diagnosing a condition.
No
The device description explicitly states it is a "photon therapy apparatus" that uses "LEDs (Light emitting diodes)" to produce light at specific wavelengths. This indicates a physical hardware component is central to the device's function, not just software. While software verification and validation are mentioned, this is for controlling the hardware, not the device itself being solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "emit energy to treat dermatological conditions" and for "temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied." These are all therapeutic applications, not diagnostic ones.
- Device Description: The description focuses on the mechanism of action (emitting specific wavelengths of light) and the physical components (LEDs, irradiators). There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or assays
The device is a therapeutic device that uses light energy to treat various conditions.
N/A
Intended Use / Indications for Use
Photon therapy apparatus use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The red light (633±8nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions.
The blue light (417±8nm wavelength) indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The Yellow light (590±8nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.
The infrared light (830±8mm wavelength) is generally use for the temporary relief of minor muscle and joint pain, atthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Product codes
GEX
Device Description
The photon therapy apparatus (BL-10) use specific wavelengths of light, produced by LEDs (Light emitting diodes), to manage aesthetic conditions. The device produces light in the red light region of the spectrum (633±8nm), in the blue light regions of the light spectrum (417±8nm), yellow light area (590±8nm) and infrared light region of light spectrum (835±8nm).
The photon therapy apparatus (BL-10) are equipped with six type of optional irradiators, each of which emits three different colors of light sources. The details of different irradiators are as follows:
Table 1 Specification of different irradiators
| REF No. | Types of irradiator | Specification |
|---|---|---|
| LT01 | RBY Irradiator | Red/Blue/Yellow light, 3 panels |
| LT02 | RBY Irradiator | Red/Blue/Yellow light, 5 panels |
| LT03 | IBY Irradiator | Infrared/Blue/Yellow light, 3 panels |
| LT04 | IBY Irradiator | Infrared/Blue/Yellow light, 5 panels |
| LT05 | IRY Irradiator | Infrared/Red/Yellow light, 3 panels |
| LT06 | IRY Irradiator | Infrared/Red/Yellow light, 5 panels |
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: Electrical safety, electromagnetic compatibility (EMC) and performance testing were performed to, and passed, the following standards:
- ANSI AAMI ES60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- IEC 60601-1: 2020 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 compatibility Requirements and tests
- IEC 60601-2-57: 2023 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 cosmetic and aesthetic use
- IEC 62471: 2006 Photobiological safety of lamps and lamp systems
Software Verification and Validation: Software documentation consistent with Basic Documentation Level of concern was submitted in this 510(k). System verification testing presented in this 510(k) demonstrated that all software requirement specifications are met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
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Xemis Medical Technology (Shenzhen) Co., Ltd. Yongfen Yang RA Engineer 1101/1102/1201/1202, Unit 1, Building 2, Hongpeng Building, Tiegang Community, Xixiang Street, Baoan Shenzhen, Guangdong 518102 China
Re: K243993
Trade/Device Name: Photon Therapy Apparatus (BL-10) 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 Dated: December 26, 2024 Received: December 26, 2024
Dear Yongfen Yang:
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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). 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-regulatory
2
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,
Image /page/2/Picture/3 description: The image shows a digital signature from "YAN FU -S". The signature includes the date and time of the signature, which is March 13, 2025, at 18:24:57. The time zone is indicated as -04'00'. The signature appears to be an electronic verification of a document or file.
for Tanisha Hithe
Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243993
Device Name Photon Therapy Apparatus (BL-10)
Indications for Use (Describe)
Photon therapy apparatus use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The red light (633±8nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions.
The blue light (417±8nm wavelength) indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The Yellow light (590±8nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.
The infrared light (830±8mm wavelength) is generally use for the temporary relief of minor muscle and joint pain, atthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
| 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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4
K243993 - 510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2025-02-26
Submitter's identifications 1.
Name: Xemis Medical Technology (Shenzhen) Co., Ltd.
Address: 1101/1102/1201/1202, Unit 1, Building 2, Hongpeng Building, Tiegang
Community, Xixiang Street, Baoan, Shenzhen, China
Contact person: Yang Yongfen
Title: RA Engineer
E-mail: yangyongfen(@ximisihn.com
Tel: 86-755-23316735
| Trade/Device Name | Photon Therapy Apparatus |
|---|---|
| Model | BL-10 |
| Product Code | GEX |
| Classification Panel | General & Plastic Surgery |
| Regulatory Class | Class II |
| Regulation Number | 21 CFR878.4810 |
| Submission type | Traditional 510(K) |
2. Subject Device Information
Predicate Device 3.
| Device name and model | K number | Manufacturer |
|---|---|---|
| LED Light Therapy Device | K222751 | Xuzhou Kernel Medical |
| Equipment Co., Ltd. | ||
| Phototherapy System | K190938 | Shanghai Apolo Medical |
| Technology Co., Ltd. | ||
| Oxylight | K200104 | RAJA Trading Company, Inc. |
Device Description 4.
The photon therapy apparatus (BL-10) use specific wavelengths of light, produced by LEDs (Light emitting diodes), to manage aesthetic conditions. The device produces light in the red light region of the spectrum (633±8nm), in the blue light regions of the light spectrum (417±8nm), yellow light area (590±8nm) and infrared light region of light spectrum (835±8nm).
The photon therapy apparatus (BL-10) are equipped with six type of optional irradiators, each of which emits three different colors of light sources. The details of different irradiators are as follows:
Table 1 Specification of different irradiators
5
| REF No. | Types of irradiator | Specification |
|---|---|---|
| LT01 | RBY Irradiator | Red/Blue/Yellow light, 3 panels |
| LT02 | RBY Irradiator | Red/Blue/Yellow light, 5 panels |
| LT03 | IBY Irradiator | Infrared/Blue/Yellow light, 3 panels |
| LT04 | IBY Irradiator | Infrared/Blue/Yellow light, 5 panels |
| LT05 | IRY Irradiator | Infrared/Red/Yellow light, 3 panels |
| LT06 | IRY Irradiator | Infrared/Red/Yellow light, 5 panels |
5. Intended use & Indication for use
Photon therapy apparatus use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The red light (633±8nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions.
The blue light (417±8nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The Yellow light (590±8nm wavelength) is generally indicated to treat dermatological
conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.
The infrared light (830±8nm wavelength) is generally use for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
| | Proposed
Device | Predicate device | Predicate
device | Predicate
device |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k Number | / | K222751 | K190938 | K200104 |
| Product Code | GEX | GEX | GEX | GEX |
| Proprietary Name | Photon Therapy
Apparatus | LED Light
Therapy Device | Phototherapy
System | Oxylight |
| Model | BL-10 | KN-7000L | HS-770 | / |
| Manufacturer | Xemis Medical
Technology | Xuzhou Kernel
Medical | Shanghai
Apolo Medical | RAJA Trading
Company, Inc. |
| | Proposed
Device | Predicate device | Predicate device | Predicate device |
| | (Shenzhen) Co.,
Ltd. | Equipment Co.,
Ltd. | Technology
Co., Ltd. | |
| | Photon Therapy
Apparatus use
of the red, blue,
yellow and
infrared regions
of the spectrum
is intended to
emit energy to
treat
dermatological
conditions. | LED Light
Therapy Device
use of the red,
blue, Yellow and
infrared regions
of the spectrum
is intended to
emit energy to
treat
dermatological
conditions. | Phototherapy
Systems use of
the red, blue
and infrared
regions of the
spectrum is
intended to
emit energy to
treat
dermatological
conditions. | The Oxylight
is intended for
dermatological
use by
physicians and
healthcare
professionals
for the
following:
LED
Technology is
intended for:
-Blue LED –
465nm - to
treat
dermatological
conditions and
specifically
indicated to
treat moderate
inflammatory
acne
vulgaris.
-Red LED
625nm- for
treatment of
superficial,
benign
vascular and
pigmented
lesions.
-Yellow LED
590nm -
treatment of
periorbital
wrinkles and
rhytides |
| Indications for Use | The red light
(633±8nm
wavelength) is
generally
indicated to
treatment of
superficial,
benign vascular,
and pigmented
lesions.
The blue light
(417±8nm
wavelength) is
generally
indicated to
treat
dermatological
conditions and
specifically
indicated to
treat moderate
inflammatory
acne vulgaris.
The yellow
light (590±8nm
wavelength) is | The red light
(633±10nm
wavelength) is
generally
indicated to
treatment of
superficial,
benign vascular,
and pigmented
lesions.
The blue light
(417±10 nm
wavelength) is
generally
indicated to treat
dermatological
conditions and
specifically
indicated to treat
moderate
inflammatory
acne vulgaris.
The Yellow light
(590±10nm
wavelength) is
generally | The blue light
(415nm
wavelength) is
generally
indicated to
treat
dermatological
conditions and
specifically
indicated to
treat moderate
inflammatory
acne vulgaris
The red light
(630nm
wavelength) is
generally
indicated to
treatment of
superficial,
benign
vascular, and
pigmented
lesions
The infrared
light (835nm | |
| | Proposed
Device | Predicate device | Predicate
device | Predicate
device |
| | generally
indicated to
treat
dermatological
conditions and
specifically
indicated for
treatment of
periorbital
wrinkles and
rhytides.
The infrared
light (830±8nm
wavelength) is
generally use
for the
temporary relief
of minor muscle
and joint pain,
arthritis and
muscle spasm;
relieving
stiffness;
promoting the
relaxation of
muscle tissue;
and to
temporarily
increase local
blood
circulation
where applied. | indicated to treat
dermatological
conditions and
specifically
indicated for
treatment of
periorbital
wrinkles and
rhytides.
The infrared
light (835±15nm
wavelength) is
generally use for
the temporary
relief of minor
muscle and joint
pain, arthritis and
muscle spasm;
relieving
stiffness;
promoting the
relaxation of
muscle tissue;
and to
temporarily
increase local
blood circulation
where applied. | wavelength) is
generally use
for the
temporary
relief of minor
muscle and
joint pain,
arthritis and
muscle spasm;
relieving
stiffness;
promoting the
relaxation of
muscle
tissue; and to
temporarily
increase local
blood
circulation
where applied. | |
| Wavelength(s)(nm) | Red light
633±8nm
Blue light
417±8nm
Yellow light
590±8nm | Red light 633 ±
10nm
Blue light
417±10nm
Yellow light
590±10nm | Red light 630
± 15nm
Blue light 415
± 15nm
Infrared 835 ±
15nm | Red light
625nm
Blue light
465nm
Yellow light
590nm |
| | Proposed
Device | Predicate device | Predicate
device | Predicate
device |
| | Infrared
830±8nm | Infrared 835 ±
15nm | | |
| Panels Type | 3 panel and 5
panel.
The panels may
emit the three
light
(red/yellow/blu
e, or infrared
/yellow/blue, or
infrared
/yellow/red)
individual or in
combination | 5 Panels
The panels may
emit the three
light
(red/blue/infrare
d, or
red/blue/yellow)
individual or in
combination | 3 panel and 4
Panel
The panels
may emit the
three light
(red, blue,
infrared)
individual or
in combination | Three type,
each head type
has only one
light. Red,
Blue, yellow. |
| Output Power | Each panel has
three different
kinds of light-
emitting diodes,
and the energy
power of the
diode is
as
follows:
Red
light:
1.51.8W1.8W
Yellow
light:
1.5
light:
Blue
2.22.5W1.4W | Each panel has
Infrared:
1.1
three different
kinds of light-
emitting diodes,
and the energy
power of the
diode is 0.5W | Each
LED
lamp bead has
4
diodes
that
emit different
colors,
the
energy power
of a
diode is 3W. | unknown |
| Maximum power
density in mW
(mW/CM²) | (1)Red:
80mW/cm²
(2)Blue:
100mW/cm2
(3)Yellow
35W/cm2 | Red light: 20~
96 mw/cm2
Blue light: 10~
120 mw/cm2
Yellow light:
5~35 mw/cm2 | (1)Red light:
115mW/cm2,
(2)Blue light:
120mW/cm²,
(3)IR:
70mW/cm²,
(4)Red/IR: | (1)Red:
100mW/cm²
(2)Blue:
45mW/cm2
(3)Yellow
35W/cm2 |
| | Proposed
Device | Predicate device | Predicate
device | Predicate
device |
| | (4)Infrared:
50mW/cm² | Infrared: ≤ 70
mw/cm ² | 120mW/cm²,
(5)Blue/IR:
150mW/cm² | |
| Standard does in
Joules | (1)Red: 96J/cm²
(2)Blue:
120J/cm²
(3)Yellow:
42J/cm²
(4)Infrared:
60J/cm² | Red light:
155J/cm2,
Blue light:
144J/cm2,
Yellow light:
42J/cm2,
IR: 84J/cm2 | (1)Red light:
138J/cm2,
(2)blue light:
144J/cm²,
(3)IR:
84J/cm²,
(4)Red/IR:
144J/cm²
(5)Blue/IR:
180J/cm² | (1)Red:
120J/cm²
(2)Blue:
54J/cm²
(3)Yellow:
42J/cm² |
| Adjustable dose
range | (1) Red light: 1-
144J/cm²
(2) Blue light:
1-180J/cm²
(3) Yellow light:
1-63J/cm²
(4) Infrared: 3-
90J/cm² | Red light: 20 ~ 96 J/cm²
Blue light: 10 ~ 120J/cm²
Yellow light: 5 ~ 35 J/cm²
Infrared: ≤ 70
J/cm²
Red/IR: 20 ~ 166
J/cm²
Blue/IR: 10 ~ 190 J/cm² | (1)Red light:
1-242J/cm²,
(2)blue light:1-
180J/cm²,
(3)IR:1-
147J/cm²,
(4)Red/IR: 1-
144J/cm2,
(5)Blue/IR:1-
180J/cm² | (1)Red light:
1-240J/cm2,
(2)blue light:
1-108J/cm2,
(3)Yellow
IR:1-84J/cm2 |
| Effective irradiation
area: (CM²) | 825cm² and
1375cm² | 900 cm² ±10% | 756cm² and
1008cm² | 500cm² and
860cm² |
| Structural style | Wheeled | Wheeled | Wheeled | Wheeled |
| Structure
composition | Main frame,
irradiator,
support arm | Main frame,
irradiator, lifting
frame | Main frame,
irradiator,
lifting frame | Irradiator and
support |
| Power supply | AC 100-240V
50/60Hz | AC 100-240V
50/60Hz | AC 100-240V
50/60Hz | AC 100-240V
50/60Hz |
| Treatment time | 20min
(Recommended
treatment time) | 20min
(Recommended
treatment time) | 20min
(Recommended treatment
time) | 20min
(Recommended treatment
time) |
| | Proposed
Device | Predicate device | Predicate device | Predicate device |
| Operation interface | Display Screen | Display Screen | Display Screen | Display Screen |
| Software | Yes | Yes | Yes | Yes |
| Safety classification | Class I | Class I | Class I | Class I |
| Standard | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-57
IEC 62471 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-57
IEC 62471 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-57
IEC 62471 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-57
IEC 62471 |
6. Summary of Substantial Equivalence
Table 2 Comparison to Predicate Device
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Image /page/9/Picture/0 description: The image shows the logo for XEMIS. The logo is in black text, except for the accent mark over the "i" and a curved line to the right of the "s", which are in red. The logo is simple and modern.
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Substantial Equivalence discussion:
The indications for use of the Photon Therapy Apparatus are the same as those for the predicate devices. Most technical specifications of the Photon Therapy Apparatus are either the same or substantially equivalent as compared to the predicate devices. There are no significant technological differences that raise new or different questions of safety or effectiveness.
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7. Non-clinical tests
The following performance data were provided in support of the substantial equivalence determination.
Electrical safety, electromagnetic compatibility (EMC) and performance
Electrical safety, EMC and performance testing were performed to, and passed, the following standards:
- · ANSI AAMI ES60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- · IEC 60601-1: 2020 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 compatibility Requirements and tests
- · IEC 60601-2-57: 2023 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 cosmetic and aesthetic use
- . IEC 62471: 2006 Photobiological safety of lamps and lamp systems
Software Verification and Validation
Software documentation consistent with Basic Documentation Level of concern was submitted in this 510(k). System verification testing presented in this 510(k) demonstrated that all software requirement specifications are met.
Clinical study 8.
Not applicable.
9. Conclusion
Based on comparing to predicate devices, the proposed device of BL-10 are determined to be Substantially Equivalent (SE) to the predicate devices, in respect of safety and effectiveness.