(201 days)
Not Found
No
The provided text describes a multi-application IPL/DPL system with different filters and handpieces for various dermatological procedures. There is no mention of AI, ML, image processing, or any data-driven algorithms that would suggest the use of AI/ML technology.
Yes
The device is intended for the treatment of various medical conditions, including benign epidermal lesions, cutaneous lesions, benign cutaneous vascular lesions, and inflammatory acne, indicating a therapeutic purpose beyond purely aesthetic applications.
No
The document describes the MULA as a system for "aesthetic and dermatological skin procedure applications" for treating various skin conditions and removing unwanted hair. Its purpose is treatment, not diagnosis. The "Intended Use / Indications for Use" section lists conditions that the device treats, but it does not describe using the device to identify or determine the presence of these conditions.
No
The device description explicitly states it is a "multi-application, multi-technology system, with an IPL&DPL handpiece and 8 different filters" and "two precision treatment heads," indicating it is a hardware-based system that uses Intense Pulsed Light/Dye Pulsed Light technology.
Based on the provided information, the MULA device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes aesthetic and dermatological procedures performed directly on the patient's skin using light energy. This is a therapeutic and cosmetic application, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a system that delivers light energy to the skin. It does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The MULA device's function is to treat skin conditions and remove hair through the application of light.
N/A
Intended Use / Indications for Use
MULA is intended for aesthetic and dermatological skin procedure applications by using multi-filtered Intense Pulsed Light/ Dye Pulsed Light. Intended Use for the 400-1200mm (including 8 filters) Light:
-
Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
-
Cutaneous lesions, including warts, scars and striae.
-
Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, poikiloderma of Civatte, facial and leg veins and venous malformations.
-
Removal of unwanted hair and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
-
Mild to moderate inflammatory Acne (Acne vulgaris)
Note: Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.
Product codes
ONF
Device Description
The MULA is a multi-application, multi-technology system, with an IPL&DPL handpiece and 8 different filters: 515nm/ 560mm/ 615nm/ 640mm/ 695nm/ Acne Filter (Notch filter 400-600 and 800-1200) and Vascular Filter (Notch filter 530-650 & 900-1200), and it also equips two precision treatment heads (38x10mm and 8mm diameter).
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
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The following tests were conducted:
- ISO 10993-5: 2009, Biological evaluation of medical devices –Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: 2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-23: 2021, Biological evaluation of medical devices - Part 23: Tests for irritation
- IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- IEC 60601-2-57 Medical electrical equipment –Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
- IEC 62471 Photobiological safety of lamps and lamp systems
Clinical Testing: Not applicable.
Conclusions: Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.
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
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
August 21, 2024
Guangzhou Ciellulu Photoelectric Technology Co., Ltd % Riley Chen Registration engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, Guangdong 518052 China
Re: K240314
Trade/Device Name: Mula (k2-a1) 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: February 1, 2024 Received: February 2, 2024
Dear Riley Chen:
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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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-devices/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 TANISHA TANISHAL.HITHE -S L. HITHE -S Date: 2024.08.21
11:54:52 -04'00'
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) K240314
Device Name MULA (K2-A1)
Indications for Use (Describe)
MULA is intended for aesthetic and dermatological skin procedure applications by using multi-filtered Intense Pulsed Light/ Dye Pulsed Light. Intended Use for the 400-1200mm (including 8 filters) Light:
-
Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
-
Cutaneous lesions, including warts, scars and striae.
-
Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, poikiloderma of Civatte, facial and leg veins and venous malformations.
-
Removal of unwanted hair and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
-
Mild to moderate inflammatory Acne (Acne vulgaris)
Note: Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.
| 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
510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
I. Submitter
Guangzhou Ciellulu Photoelectric Technology Co., Ltd 11/F, Building 1, Haihua Science & Technology Innovation Park, No. 62, Jinghu Avenue, Huadu District, Guangzhou Guangdong, China Post code: 510800
Jackie Zheng Title: General Manager Assistant Tel.: +86 15016678581 Email: 849543883@qq.com
Date of preparation: 2024-08-19
II. Device
Name of Device: MULA (K2-A1)
Common or Usual Name: Powered Light Based Non-Laser Surgical Instrument Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: ONF Regulation Number: 21 CFR 878.4810
III. Predicate Device & Reference Device
Predicate devices:
| 510(k) Number | Predicate Device | Product code |
|---|---|---|
| K193500 | Stellar M22 for Intense Pulsed Light (IPL) and | |
| Laser System | GEX, ONF, ONG | |
| K193072 | Lucent : IPL | ONF |
IV. Device Description
The MULA is a multi-application, multi-technology system, with an IPL&DPL handpiece and 8 different filters: 515nm/ 560mm/ 615nm/ 640mm/ 695nm/ Acne Filter (Notch filter 400-600 and 800-1200) and Vascular Filter (Notch filter 530-650 & 900-1200), and it also equips two precision treatment heads (38x10mm and 8mm diameter).
5
V. Indications for Use
MULA is intended for aesthetic and dermatological skin procedure applications by using multi-filtered Intense Pulsed Light/ Dye Pulsed Light. Intended Use for the 400-1200nm (including 8 filters) Light:
-
- Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
-
- Cutaneous lesions, including warts, scars and striae.
-
- Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, facial and leg veins and venous malformations.
-
- Removal of unwanted hair and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
-
- Mild to moderate inflammatory Acne (Acne vulgaris)
Note: Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.
Comparison of Indications for Use: The indications for use of the subject device is comparable to the indications for use of the predicate devices.
VI. Comparison of Technological Characteristics
| Device & Predicate Device(s): | K240314
(Subject) | K193500
(Predicate) | K193072
(Predicate) |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| General Device Characteristics | | | |
| Light Source | Intense Pulsed
Light
Dye-pulsed Light | Intense Pulsed
Light | Intense Pulsed Light |
| Wavelength (nm) | 400-1200 | 400-1200 | 400-1200 |
| Filters | 515-950nm
560-950nm
590-950nm
615-950nm
640-950nm
695-950nm
Acne (400-600 &
800-1200)
Vascular (530-650
& 900-1200) | 515/560/590/615/6
40/695/755
Acne (400-600 &
800-1200)
Vascular (530-650
& 900-1200) | 430-980nm
515-980nm
560-980nm
585-980nm
640-980nm
700-980nm |
| Pulse duration (ms) | 1-30 | 20 | 3-35 |
| Pulse interval (ms) | 1-99 | 5-150 | 0-50 |
6
| Pulse Sequences | 1, 2, or 3 sub-pulses | 1, 2, or 3 sub-pulses | 1, 2, 3, toning (ST Mode:
430/515/560/585/640)
1, 2, 3 (HR mode: 700) |
|---------------------------------|----------------------------|----------------------------------------------------|-----------------------------------------------------------------------------|
| Spot size (cm²) | 14mm X 38mm
(5.32 cm²) | 8 mm X 15 mm
(1.2 cm²) | 15 mm X 40 mm |
| | 38 mm X 10 mm
(3.8 cm²) | 15 mm X 35 mm
(5.25 cm²) | |
| | 8 mm round (0.5 cm²) | 6 mm round (0.3 cm²) | |
| Maximum Fluence (J/cm²) | 2-40 | 35 (@ 8 X 15 mm², 15 X 35 mm²)
56 (@ 6mm round) | 6-40 |
| Repetition Rate (Hz) | 1-5 | 1 | Unknown |
| Contact Sapphire Cooling T (°C) | 5-20 | 0-10 (Rectangular)
0-15 (Round) | Range:-5 to 20
(Chiller @ 15) |
Note: Not all combinations of technical parameters are permissible in the subject device.
VII. Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The following tests were conducted:
-
ISO 10993-5: 2009, Biological evaluation of medical devices –Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10: 2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
-
ISO 10993-23: 2021, Biological evaluation of medical devices - Part 23: Tests for irritation
-
IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
-
IEC 60601-2-57 Medical electrical equipment –Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
-
IEC 62471 Photobiological safety of lamps and lamp systems
VIII. Clinical Testing
7
Not applicable.
IX. Conclusions
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.