(189 days)
No
The document does not mention AI, ML, or any related technologies. The device description and performance studies focus on standard laser technology and safety testing.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for various "surgical and aesthetic applications," including the "treatment" of numerous medical conditions and cosmetic issues, and that it is "therapeutic." Moreover, the "Summary of Performance Studies" indicates conformity with IEC 60601-2-22, which "indicates the conformity of mJOULE system with the particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnose laser equipment."
No
The mJoule 1064 laser system is intended for surgical and aesthetic applications, specifically for treatment purposes like coagulation, hemostasis, reduction of pigmentation, hair removal, and incision/excision, rather than for diagnosing conditions.
No
The device description explicitly states that the mJOULE 1064nm Laser System consists of a console and laser delivery accessories, including a power supply, cooling system, fiber arm delivery system with a handpiece, and a footswitch. These are all hardware components. While software is mentioned and verified/validated, it is part of a larger hardware system.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes a laser system used for surgical and aesthetic applications directly on the patient's body (e.g., treating skin lesions, removing hair, performing surgery). IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health.
- Device Description: The device description details a laser system with a console, delivery accessories, and a handpiece that delivers optical energy to the treatment site. This is consistent with a therapeutic or surgical device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The device is a therapeutic laser system used for various medical procedures performed directly on the patient.
N/A
Intended Use / Indications for Use
The mJoule 1064 laser systems and accessories is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastic, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.
Dermatology:
Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lake, leg veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The lasers are indicated for pigmented 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.
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Removal of unwanted hair, for the stable long term. or permanent hair reduction through selective of melanin in hair follicles, and for the treatment for pseudo folliculitis barbae (PFB). The mJoule 1064 laser system and accessories is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The mJoule 1064 laser system and accessories is indicated for the treatment of facial wrinkles.
Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and T.
mentagrophytes, and/or yeasts Candida albicans, etc.).
Treatment of Aphthous Ulcers.
Excision and Vaporization of Herpes Simplex I and II.
Laser assisted uvulopalatoplasty (LAUP).
Laser assisted lipolysis.
Treatment of mild to moderate inflammatory acne vulgaris.
Surgical Applications:
Incision/excision and cutting, ablation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastic, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g., menorrhagia) and urology.
Product codes
GEX
Device Description
The mJOULE 1064nm Laser System consists of a console and laser delivery accessories. It uses focusing optics to deliver optical energy to the treatment site. The control console houses the power supply, cooling system, fiber arm delivery system with a handpiece. The user activates laser emission by means of a footswitch.
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)
Performance: FDA recognized consensus standards were utilized to evaluate the mJOULE system for non-clinical performance. These included electrical, mechanic EMC testing, usability and essential performance of the mJOULE system.
IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 applicable for the general requirements concerning basic safety and essential performance that are applicable to medical electrical equipment. Examples of tests performed on the mJOULE system based upon this standard are power input, humidity, durability of markings, leakage current, dielectric strength, excessive temperature, push & impact tests, etc. IEC 60601-1-2: 2014 indicates the conformity of the mJOULE system to the basic safety and essential performance of medical equipment (ME) in the presence of electromagnetic disturbance and for electromagnetic emission of ME systems. Examples of the tests performed are electrostatic discharge immunity test, electromagnetic field immunity, transient immunity, power frequency magnetic field immunity, voltage dips/interruptions immunity tests, etc.
IEC 60601-1-6: 2010, AMD:2013 indicates the usability of mJOULE system and its associated accessories. Examples of evaluations performed are usability of engineering principles, hazards related to usability, user interface, medical benefits versus risks, etc.
IEC 60601-2-22: 2007(Third edition) +A1:2012 for use in conjunction with IEC 60601-1:2005 (Third edition) + A1:2012 indicates the conformity of mJOULE system with the particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnose laser equipment. Examples of test performed are: Interruption of power supply, indication of laser output, indications of parameters relevant to safety and emergency stop.
IEC 60825-1: 2014 (Third edition) applicable for the safety of mJOULE system and its delivery accessories. An Examples of test performed is: Determination of accessible emission levels.
Biocompatibility: The biocompatibility is not applicable for mJOULE ClearSilk delivery system since there is no tissue contacting component for its indications. ClearV handpiece application in treating the vascular lesions is however a tissue contacting component in the mJOULE system. The skin touching surface of the ClearV handpiece for the vascular lesion treatment is a gold framed sapphire window spacer that provide cooling to the skin. The biocompatibility evaluation of the sapphire window and the gold frame in the ClearV handpiece was conducted in accordance with the international standard ISO-10993-1 "Biological evaluation of medical devices-part1: evaluation and testing within a risk management process." As identified by FDA (See attachment VI).
Software: Software verification and validation testing documents are provided in attachment VII of the document as recommended by "Guidance for the content of premarket submissions for software contained in medical devices." Considered as "Moderate" level of concern. All the items in the software risk analysis, software development procedure, cybersecurity risk analysis, software requirement specification, software design documentation, software test plan and traceability analysis met the requirements.
Sterility: The mJOULE system has no component or accessory that is sold sterile.
Shelf-life: Shelf-life is not applicable for mJOULE system because of low likelihood of time-dependent product degradation.
Conclusion: The conclusions drawn from the non-clinical tests demonstrate that the mJOULE system is safe and effective, and performs as well as or better than the legally marketed device predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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Image /page/0/Picture/0 description: The image contains the logo of 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 are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 15, 2022
Sciton, Inc Jay Patel VP of Regulatory Affairs 925 Commercial Street Palo Alto, California 94303
Re: K213350
Trade/Device Name: mJOULE System and Accessories 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: March 14, 2022 Received: March 17, 2022
Dear Jay Patel:
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.
1
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 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) K213350
Device Name mJOULE System and Accessories
Indications for Use (Describe)
The mJoule 1064 laser systems and accessories is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastic, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.
Dermatology:
Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lake, leg veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The lasers are indicated for pigmented 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.
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Removal of unwanted hair, for the stable long term. or permanent hair reduction through selective of melanin in hair follicles, and for the treatment for pseudo folliculitis barbae (PFB). The mJoule 1064 laser system and accessories is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The mJoule 1064 laser system and accessories is indicated for the treatment of facial wrinkles.
Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and T.
mentagrophytes, and/or yeasts Candida albicans, etc.).
Treatment of Aphthous Ulcers.
Excision and Vaporization of Herpes Simplex I and II.
Laser assisted uvulopalatoplasty (LAUP).
Laser assisted lipolysis.
Treatment of mild to moderate inflammatory acne vulgaris.
Surgical Applications:
Incision/excision and cutting, ablation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastic, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g., menorrhagia) and urology.
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.
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510(k) Summary K213350
| Submitter: | Sciton, Inc. |
|---|---|
| Address: | 925 Commercial Street, Palo Alto, CA 94303 |
| Phone: | (650) 493-9155 |
| Fax: | (650) 493-9146 |
| Contact Person: | Jay M. Patel, VP of Regulatory Affairs |
| Date Prepared: | October 4, 2021 |
| Device Trade Name: | mJOULE System |
| Common Name: | Laser Powered Surgical Device (and Accessories) |
| Classification Name: | Laser Surgical Instrument, 21 CFR 878.4810. |
| Classification Product | |
| Code: | GEX |
| Legally Marketed | |
| Predicate Device: | K191842 Quanta System Discovery Pico Family |
| K182088 Fotona Dynamis Pro Family | |
| K023881 Sciton Profile 1064 Laser System and Accessories | |
| Description of the | |
| mJOULE 1064 nm Laser | |
| System: | The mJOULE 1064nm Laser System consists of a console and laser delivery |
| accessories. It uses focusing optics to deliver optical energy to the treatment site. | |
| The control console houses the power supply, cooling system, fiber arm delivery | |
| system with a handpiece. The user activates laser emission by means of a footswitch. | |
| Indications for Use: | The mJOULE 1064 laser systems and accessories is intended for use in the medical |
| specialties of general and plastic surgery, dermatology, endoscopic/laparoscopic | |
| general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), | |
| neurosurgery, oculoplastic, orthopedics, pulmonary/thoracic surgery and urology for | |
| surgical and aesthetic applications. |
Dermatology:
Coagulation and hemostasis of benign vascular lesions such as, but not limited to
port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lake, leg veins
and spider veins. The lasers are also intended for the treatment of benign pigmented
lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots),
café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags,
keratoses, tattoos (significant reduction in the intensity of black and/or blue/black
tattoos) and plaques. The lasers are indicated for 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.
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is
an integral part of the scar.
Removal of unwanted hair, for the stable long term, or permanent hair reduction
through selective targeting of melanin in hair follicles, and for the treatment for
pseudo folliculitis barbae (PFB). The mJOULE 1064 laser system and accessories is
indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The mJOULE 1064 laser system and accessories is indicated for the treatment of
facial wrinkles.
Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes
Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
Treatment of Aphthous Ulcers.
Excision and Vaporization of Herpes Simplex I and II.
Laser assisted uvulopalatoplasty (LAUP). |
| | Laser assisted lipolysis.
Treatment of mild to moderate inflammatory acne vulgaris. |
| | Surgical Applications:
Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the
performance of surgical applications in endoscopy/laparoscopy, gastroenterology,
general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery,
oculoplastic, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology
(e.g., menorrhagia) and urology. |
| Technological
Characteristics: | The mJOULE System shares the same indications for use, and as noted below,
shares similar design features (including wavelength, laser medium and delivery
systems, power supply, cooling and control system), functional features
(including power output, repetition rate, energy, spot size and fluence), and is
therefore substantially equivalent to the above legally marketed predicate
devices. |
5
6
Comparative representation of the Quanta System Discovery Pico Family (K191842), the Fotona Dynamis Pro Family (K182088), the Sciton Profile 1064 Laser System and Accessories (K023881) which are the
predicate for the newly submitted device (mJOULE 1064 Laser system and Acce
| Specification | Predicate Device | Primary Predicate
Device | Predicate Device | This Application | Substantially
Equivalent | |
|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------|-----------------------------|--|
| 510(k) Number | K191842 | K182088 | K023881 | N/A | -- | |
| Product | Quanta System
Discovery Pico
Family | Fotona Dynamis Pro
Family | Sciton Profile 1064
Laser System and
Accessories | mJOULE 1064 Laser
System and
Accessories | -- | |
| Regulation | GEX, 21 CFR 878-
4810 | GEX, 21 CFR 878-
4810 | GEX, 21 CFR 878-
4810 | GEX, 21 CFR 878-
4810 | Yes | |
| CDRH Laser
Class | Class 4 | Class 4 | Class 4 | Class 4 | Yes | |
| Energy Source | Nd: YAG, and Ruby | Nd: YAG | Nd: YAG | Nd: YAG | Yes | |
| Device Class | ll | ll | ll | 11 | Yes | |
| Laser
Wavelength (nm) | 1064 | 1064 | 1064 | 1064 | Yes | |
| Maximum
Repetition Rate | Up to 10 Hz | Up to 100 Hz | 15 Hz | 20 Hz | Yes | |
| Pulse Duration | 0.3 - 50 ms | 0.1 - 50 ms | 0.1 - 300 ms | 0.1 - 300 ms | Yes | |
| Spot Size | 2 to 8 mm | 3 – 9 mm | 0.5 – 15 mm | 0.5 – 15 mm | Yes | |
| Fluence | Up to 300 joules/cm² | Up to 300 joules/cm² | Up to 400 joules/cm² | Up to 400 joules/cm² | Yes | |
| Utilities | 200-240 VAC, 50/60
Hz | 100-240 VAC | 230 VAC, 50/60 Hz | 230 VAC, 50/60 Hz | Yes | |
| Aiming Beam | 650 nm (red) | 635 nm/650 nm (red)
or 520-535 nm
(green);