(240 days)
Not Found
No
The document describes a laser system for dermatological procedures and does not mention any AI or ML components in its description, intended use, or performance studies.
Yes.
The device is used for dermatological procedures and treatment of various skin conditions like dyschromia, cutaneous lesions, wrinkles, and scars, which falls under therapeutic use.
No
The device description and intended use clearly state that the Multifrax Laser System is used for dermatological procedures and treatments like coagulation, skin resurfacing, treatment of dyschromia, lesions, wrinkles, and scars, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly details hardware components such as laser sources, batteries, a handpiece tip with sensors, and a touch screen display. The performance studies also include testing for electrical safety, electromagnetic compatibility, and laser equipment safety, which are relevant to hardware. While software validation is mentioned, it is in the context of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Multifrax Laser System is described as a non-ablative fractional laser system used for dermatological procedures directly on the skin. Its intended uses involve treating skin conditions and performing skin resurfacing.
- Mode of Action: The device works by delivering laser pulses to the skin, creating microdots of irradiated tissue. This is a direct interaction with the body, not an analysis of a specimen taken from the body.
Therefore, the Multifrax Laser System falls under the category of therapeutic or surgical medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
1550 nm: The Multifrax 1550 nm laser is indicated for use in dermatological procedures requiring coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.
1927 nm: The Multifrax 1927 mm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles).
Product codes
ONG
Device Description
The Multifrax Laser System provides non-ablative fractional treatment using the 1550 nm and 1927 nm wavelengths. The mode of action is delivering a series of light pulses in a row as the handpiece tip is moved across the skin which leaves a pattern of microdots (Micro Thermal Zone (MTZ)) of irradiated skin.
Multifrax Laser System is a dual-wavelength diode laser system comprising two laser sources emitting at 1550 and 1927 nm and generating fine pulses of energy.
- Multifrax is a non-ablative and non-invasive fractional laser device.
- Multifrax is a light portable laser combining a small laser unit and 2 long lasting rechargeable batteries equipped with a belt clip.
- Multifrax offers optimized technical characteristics: adjustable treatment width, adjustable distance between laser pulses, distal tip with integrated high-performance movement and skin contact tracking sensors, and color touch screen display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D) by trained healthcare professionals
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 testing was performed to verify that the proposed device met all design specifications and is substantially equivalent to the predicate device. Testing was performed to the following standards and the Multifrax Laser System was found to meet the requirements:
- Electrical safety per ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- Electromagnetic compatibility per IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests
- Usability per IEC 60601-1-6 2010, AMD 1: 2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Usability
- Laser equipment safety per IEC 60601-2-22 Medical electrical equipment Part 2: . Particular requirements for the basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
- Laser safety per IEC 60825-1:2014 Safety of laser products-Part 1: Equipment classification and requirements
- Software validation and verification per IEC 62304:2006 Medical device software-. Software life cycle processes
- Biocompatibility per ISO 10993-23:2021 Biological evaluation of medical devices-Part . 23: Tests for irritation; ISO 10993-10:2021 Biological evaluation of medical devices-Part 10 :Tests for irritation and skin sensitization; and ISO 10993-5 :2009 Third edition Biological evaluation of medical devices-Part 5 : Tests for in vitro cytotoxicity
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 3, 2022
Paradigm Medical Corporation % Maureen O'connell President O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, Massachusetts 02180
Re: K213332
Trade/Device Name: Multifrax Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: ONG Dated: May 6, 2022 Received: May 9, 2022
Dear Maureen O'connell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Purva Pandya, D.Eng. 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
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Indications for Use
510(k) Number (if known) K213332
Device Name Multifrax Laser System
Indications for Use (Describe)
1550 nm: The Multifrax 1550 nm laser is indicated for use in dermatological procedures requiring coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.
1927 nm: The Multifrax 1927 mm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles).
| 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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510(k) SUMMARY
Paradigm Medical Corporation Multifrax Laser System K213332
510(k) Owner
Paradigm Medical 7371 Los Brazos San Diego, CA 92127
Submission Correspondent
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham. MA 02180 Phone: 978-207-1245
Date Prepared: June 3, 2022
Trade Name of Device
Multifrax Laser System
Common or Usual Name
Powered laser surgical instrument with microbeam/fractional output
Classification Name
Laser surgical instrument for use in general and plastic surgery and dermatology; 21 C.F.R. $878.4810 Class II Product Code: ONG
Predicate Device
Solta Medical, Inc. Fraxel Dual 1550/1927 Laser System cleared in K130193
Device Description
The Multifrax Laser System provides non-ablative fractional treatment using the 1550 nm and 1927 nm wavelengths. The mode of action is delivering a series of light pulses in a row as the handpiece tip is moved across the skin which leaves a pattern of microdots (Micro Thermal Zone (MTZ)) of irradiated skin.
Multifrax Laser System is a dual-wavelength diode laser system comprising two laser sources emitting at 1550 and 1927 nm and generating fine pulses of energy.
- Multifrax is a non-ablative and non-invasive fractional laser device. ●
4
- Multifrax is a light portable laser combining a small laser unit and 2 long lasting ● rechargeable batteries equipped with a belt clip.
- Multifrax offers optimized technical characteristics: adjustable treatment width, adjustable ● distance between laser pulses, distal tip with integrated high-performance movement and skin contact tracking sensors, and color touch screen display.
Indications for Use
1550 nm: The Multifrax 1550 nm laser is indicated for use in dermatological procedures requiring coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.
1927 nm: The Multifrax 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue. treatment of actinic keratosis, and treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles).
Substantial Equivalence
Paradigm Medical believes that the Multifrax described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to a legally marketed predicate device that is a Class II medical device which is the Fraxel Dual 1550/1927 nm Laser System cleared in K130193. The table below compares the properties of the two devices.
| Characteristic | Multifrax | Fraxel Dual 1550/1927 nm
Laser System |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Paradigm Medical | Solta Medical, Inc. |
| 510(k)
Number | - | K130193 |
| Product Code | ONG | GEX |
| Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Indications
for Use | 1550 nm: The Multifrax 1550 nm laser
is indicated for use in dermatological
procedures requiring coagulation of
soft tissue, as well as for skin
resurfacing procedures. It is also
indicated for treatment of dyschromia
and cutaneous lesions, such as, but not
limited to lentigos (age spots), solar
lentigos (sun spots), actinic keratosis,
and melasma, and for treatment of
periorbital wrinkles, acne scars and
surgical scars.
1927 nm: The Multifrax 1927 nm laser
is indicated for use in dermatological
procedures requiring the coagulation of
soft tissue, treatment of actinic
keratosis, and treatment of pigmented
lesions such as, but not limited to | 1550: The Fraxel 1550 nm laser is
indicated for use in dermatological
procedures requiring coagulation of soft
tissue, as well as for skin resurfacing
procedures. It is also indicated for
treatment of dyschromia and cutaneous
lesions, such as, but not limited to
lentigos (age spots), solar lentigos (sun
spots), actinic keratosis, and melasma,
and for treatment of periorbital wrinkles,
acne scars and surgical scars.
1927 nm: The Fraxel 1927 nm laser is
indicated for use in dermatological
procedures requiring the coagulation of
soft tissue, treatment of actinic keratosis,
and treatment of pigmented lesions such
as, but not limited to lentigos (age spots), |
5
| lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles). | solar lentigos (sun spots) and ephiledes (freckles). | |
|---|---|---|
| Clearance | ||
| Type | Prescription | Prescription |
| User | Healthcare Professional | Healthcare Professional |
| Operating | ||
| Principles | Non-ablative treatment | Non-ablative treatment |
| Laser Source | Laser diode | Erbium fiber |
| Thulium fiber | ||
| Delivery | ||
| System | Handpiece | Fiber delivery |
| to Handpiece | ||
| Laser | ||
| Wavelength | 1550 nm | |
| 1927 nm | 1550 nm | |
| 1927 nm | ||
| Pulse Energy | 4 to 70 mJ (1550 nm) | |
| 1 to 20 mJ (1927 nm) | 4 to 70 mJ (1550 nm) | |
| 5 to 20 mJ (1927 nm) | ||
| Tissue | ||
| Contact | Disposable contact tip | Disposable contact tips |
| Power source | 2 rechargeable batteries | Power supply |
The intended use of the Multifrax as well as the indications for use are identical. Both are prescription devices for use by trained healthcare professionals for non-ablative dermatological laser treatment. The devices have the same technological characteristics. Both lasers are 1550 nm and 1927 nm diode lasers. Both are delivered to the patient via a handpiece with a contact tip. The upper pulse energy of both devices is the same for both wavelengths. The scaming shape is a single line for both devices. Neither device has an aiming beam. Both devices are software controlled and operated via a touchscreen.
Performance Data
Non-clinical testing was performed to verify that the proposed device met all design specifications and is substantially equivalent to the predicate device. Testing was performed to the following standards and the Multifrax Laser System was found to meet the requirements:
- Electrical safety per ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, ● C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- . Electromagnetic compatibility per IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests
- Usability per IEC 60601-1-6 2010, AMD 1: 2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Usability
- Laser equipment safety per IEC 60601-2-22 Medical electrical equipment Part 2: . Particular requirements for the basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
- Laser safety per IEC 60825-1:2014 Safety of laser products-Part 1: Equipment ● classification and requirements
6
- Software validation and verification per IEC 62304:2006 Medical device software-. Software life cycle processes
- Biocompatibility per ISO 10993-23:2021 Biological evaluation of medical devices-Part . 23: Tests for irritation; ISO 10993-10:2021 Biological evaluation of medical devices-Part 10 :Tests for irritation and skin sensitization; and ISO 10993-5 :2009 Third edition Biological evaluation of medical devices-Part 5 : Tests for in vitro cytotoxicity
Conclusion
Based on the substantial equivalence discussion and the performance testing, the Multifrax Laser System is substantially equivalent to the Fraxel Dual 1550/1927 nm Laser System.