(189 days)
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.
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.
1. Acceptance Criteria and Device Performance:
The provided document does not explicitly present a table of acceptance criteria and reported device performance in the typical format of quantitative metrics (e.g., sensitivity, specificity, accuracy) against predefined thresholds. Instead, it demonstrates substantial equivalence to predicate devices based on shared technical characteristics and indications for use.
The "acceptance criteria" are implied by the substantial equivalence determination process itself. The device (mJOULE System) is deemed to meet the acceptance criteria because its specifications and performance are comparable to legally marketed predicate devices, and it has successfully passed various recognized safety and performance standards.
Here's a table summarizing the comparative technical specifications that serve as the basis for demonstrating equivalence:
| Specification | Predicate Device (K191842) | Primary Predicate Device (K182088) | Predicate Device (K023881) | This Application (mJOULE 1064 Laser System) | Substantially Equivalent |
|---|---|---|---|---|---|
| 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 | II | II | II | II | 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); <1 mW | 650 nm (red); <1 mW | 650 nm (red); <1 mW | Yes |
| Delivery System | Fiber/Arm | Fiber | Arm | Fiber/Arm | Yes |
| Handpiece | Single spot or scanner | Single spot or scanner | Single spot or scanner | Single spot or scanner | Yes |
| Power (Watts) | N/A | Up to 80 W | 50 W | 50 W | Yes |
| Cooling System | Water to Air | Water to Air | Water to Air | Water to Air | Yes |
| Control System | Microprocessor | Microprocessor | Microprocessor | Microprocessor | Yes |
| Energy Monitor | Display Indicates Energy Delivered to Tissue | Display Indicates Energy Delivered to Tissue | Display Indicates Energy Delivered to Tissue | Display Indicates Energy Delivered to Tissue | Yes |
| Safety | Safety Eyewear and Remote Interlock Connector | Safety Eyewear and Remote Interlock Connector | Safety Eyewear and Remote Interlock Connector | Safety Eyewear and Remote Interlock Connector | Yes |
| User Interface | Touch screen control | Touch screen control | Touch screen control | Touch screen control | Yes |
| Indications for Use | See Section 1.1 (Similar) | See Section 1.2 (Similar) | See Section 1.3 (Similar) | See Section 1.4 (Similar) | Yes |
The study that proves the device meets the acceptance criteria is the non-clinical performance testing outlined in the "Summary of Non-clinical Tests" section. This testing demonstrates that the mJOULE System is safe and effective and performs comparably to its predicate devices.
2. Sample Size for the Test Set and Data Provenance:
The document describes non-clinical performance and safety testing against recognized consensus standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1) and biocompatibility testing (ISO-10993-1).
- Sample Size: For instrument performance and safety tests, the "sample size" typically refers to the number of devices or components tested. The document does not specify the exact number of mJOULE systems or components tested for each standard. This is common for this type of submission, as the focus is on demonstrating compliance with recognized standards rather than a broad statistical analysis of device performance across a large population. For biocompatibility, it mentions evaluating the sapphire window and gold frame of the ClearV handpiece.
- Data Provenance: The testing was prospective in the sense that it was conducted on the mJOULE system and its accessories specifically to demonstrate compliance for this submission. The "country of origin of the data" is not explicitly stated, but it would have been generated in a controlled testing environment, likely at the manufacturer's facilities or accredited testing laboratories.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable in this context. The "ground truth" for non-clinical performance and safety testing is established by recognized international standards (e.g., IEC, ISO) and regulatory requirements (e.g., basic safety, essential performance, EMC, usability). The device's performance is measured against these established engineering and safety benchmarks, not against expert interpretation of clinical outcomes for a specific disease or condition.
For biocompatibility, the ground truth is established by the ISO 10993-1 standard, which outlines methods for evaluating biological reactions to medical devices. This involves expert toxicologists and material scientists interpreting the results against established safety thresholds.
4. Adjudication Method for the Test Set:
This is not explicitly applicable in the context of non-clinical device testing. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or patient outcomes, where there might be inter-reader variability.
For performance and safety testing, the results are objectively measured against predefined criteria within the standards. Any discrepancies or failures would lead to further investigation and design modifications until compliance is achieved. There isn't a "consensus" process for interpreting a test result being within or outside a specification, but rather an objective verification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was NOT done.
This type of study is specifically designed to evaluate the impact of a medical device (often AI-assisted) on the diagnostic accuracy or treatment decisions of human readers. The mJOULE System is a laser system for surgical and aesthetic applications, not an AI-driven diagnostic or interpretative device that assists human readers. The submission focuses on demonstrating substantial equivalence in terms of technical characteristics and existing indications for use, without introducing new clinical claims that would necessitate an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This concept is not directly applicable. The mJOULE system itself is a physical laser device operated by a human. While it has software ("Software verification and validation testing documents are provided..."), the "standalone performance" of the algorithm is integrated into the device's overall function and assessed through the mentioned performance and safety standards. There isn't an "algorithm only" performance that produces clinical outputs independent of the human operator and the device hardware, as might be the case for an AI diagnostic algorithm. The software is part of the control system that ensures the device operates safely and as intended.
7. The Type of Ground Truth Used:
The "ground truth" for this submission is multi-faceted, based on:
- Compliance with Recognized Consensus Standards: The primary ground truth is established by international standards such as IEC 60601 series, IEC 60825-1, and ISO 10993-1. These standards define the acceptable limits for electrical safety, electromagnetic compatibility, usability, essential performance, laser safety, and biocompatibility.
- Predicate Device Equivalence: A significant part of the submission relies on demonstrating that the mJOULE System's technical characteristics and indications for use are substantially equivalent to legally marketed predicate devices. The "ground truth" here is the established safety and effectiveness of those predicate devices, as previously cleared by the FDA.
- Software Verification and Validation: For software, the ground truth is compliance with specified software requirements and successful execution of test cases as per "Guidance for the content of premarket submissions for software contained in medical devices."
8. The Sample Size for the Training Set:
This information is not applicable. The mJOULE System, as described, is a physical laser device and does not appear to employ machine learning or artificial intelligence in a way that would require a "training set" for an algorithm. The software mentioned is for control, safety, and usability, which typically undergoes traditional software verification and validation, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable because there is no mention of a training set or machine learning algorithm in the provided document.
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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.
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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 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 ProductCode: | GEX |
| Legally MarketedPredicate Device: | K191842 Quanta System Discovery Pico FamilyK182088 Fotona Dynamis Pro FamilyK023881 Sciton Profile 1064 Laser System and Accessories |
| Description of themJOULE 1064 nm LaserSystem: | The mJOULE 1064nm Laser System consists of a console and laser deliveryaccessories. It uses focusing optics to deliver optical energy to the treatment site.The control console houses the power supply, cooling system, fiber arm deliverysystem 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 medicalspecialties of general and plastic surgery, dermatology, endoscopic/laparoscopicgeneral surgery, gastroenterology, gynecology, otorhinolaryngology (ENT),neurosurgery, oculoplastic, orthopedics, pulmonary/thoracic surgery and urology forsurgical and aesthetic applications.Dermatology:Coagulation and hemostasis of benign vascular lesions such as, but not limited toport wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lake, leg veinsand spider veins. The lasers are also intended for the treatment of benign pigmentedlesions 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/blacktattoos) and plaques. The lasers are indicated for pigmented lesions to reduce lesionsize, 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 isan integral part of the scar.Removal of unwanted hair, for the stable long term, or permanent hair reductionthrough selective targeting of melanin in hair follicles, and for the treatment forpseudo folliculitis barbae (PFB). The mJOULE 1064 laser system and accessories isindicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.The mJOULE 1064 laser system and accessories is indicated for the treatment offacial wrinkles.Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytesTrichophyton 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 theperformance 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. | |
| TechnologicalCharacteristics: | The mJOULE System shares the same indications for use, and as noted below,shares similar design features (including wavelength, laser medium and deliverysystems, power supply, cooling and control system), functional features(including power output, repetition rate, energy, spot size and fluence), and istherefore substantially equivalent to the above legally marketed predicatedevices. |
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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 PredicateDevice | Predicate Device | This Application | SubstantiallyEquivalent | |
|---|---|---|---|---|---|---|
| 510(k) Number | K191842 | K182088 | K023881 | N/A | -- | |
| Product | Quanta SystemDiscovery PicoFamily | Fotona Dynamis ProFamily | Sciton Profile 1064Laser System andAccessories | mJOULE 1064 LaserSystem andAccessories | -- | |
| Regulation | GEX, 21 CFR 878-4810 | GEX, 21 CFR 878-4810 | GEX, 21 CFR 878-4810 | GEX, 21 CFR 878-4810 | Yes | |
| CDRH LaserClass | 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 | |
| LaserWavelength (nm) | 1064 | 1064 | 1064 | 1064 | Yes | |
| MaximumRepetition 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, 50/60Hz | 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); <1 mW | 650 nm (red); <1 mW | 650 nm (red); <1 mW | Yes | |
| Delivery System | Fiber/Arm | Fiber | Arm | Fiber/Arm | Yes | |
| Handpiece | Single spot orscanner | Single spot orscanner | Single spot orscanner | Single spot orscanner | Yes | |
| Power (Watts) | N/A | Up to 80 W | 50 W | 50 W | Yes | |
| Cooling System | Water to Air | Water to Air | Water to Air | Water to Air | Yes | |
| Control System | Microprocessor | Microprocessor | Microprocessor | Microprocessor | Yes | |
| Energy Monitor | Display IndicatesEnergy Delivered toTissue | Display IndicatesEnergy Delivered toTissue | Display IndicatesEnergy Delivered toTissue | Display IndicatesEnergy Delivered toTissue | Yes | |
| Safety | Safety Eyewear andRemote InterlockConnector | Safety Eyewear andRemote InterlockConnector | Safety Eyewear andRemote InterlockConnector | Safety Eyewear andRemote InterlockConnector | Yes | |
| ConsoleDimension | 20.8" x 41" x 42" | N/A | 14" x 21" x 41" | 12" x 15" x 43" | Yes | |
| User Interface | Touch screen control | Touch screen control | Touch screen control | Touch screen control | Yes | |
| Indications forUse | See section 1.1 | See section 1.2 | See section 1.3 | See section 1.4 | Yes | |
| Note: The IFU for K191842 and K182088 mentioned in this table is not the complete IFU but only the IFU related to the YAG1064 nm laser. |
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Section 1.1 (K191842)
Removal of unwanted hair. for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin.
Photocoaqulation and hemostasis of benign vascular lesions, such as, but not limited to port wine stains, hemaongiomae, warts, telangiectasia, rosacea, Venus Lake, leg veins and Spider veins. Coagulation and hemostasis of soft tissue.
Treatment of wrinkles.
Treatment of mild to moderate inflammatory acne vulgaris.
Section 1.2 (K182088)
The Dynamic Nd: YAG laser is intended for incision, ablation, vaporization and hemostasis of vascular lesions and soft tissue in various dermatological areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI.
Surgical incision, excision, vaporization, ablation and coagulation of soft tissue is included, striated and smooth tissue, muscle, cartilage, membrane, lymph vessels and nodes, organs and glands, fibroma removal, frenectomy and frenotomy.
Treatment of Aphthous Ulcers.
Excision and Vaporization of Herpes Simplex I and II.
Laser assisted uvulopalatoplasty (LAUP).
Laser assisted lipolysis.
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatick I-VI, including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Treatment of wrinkles.
Treatment of wrinkles with S11 scanner.
Treatment of mild to moderate inflammatory acne vulgaris.
Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemangioma, warts, telangiectasia, rosacea, venous lake, leg veins and spider veins.
Podiatry (ablation, vaporization, incision, and coagulation of soft tissue) including: Matrixectomy, Radical nail excision, Periungual and subungual warts, Plantar warts, Neuromas.
Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities.
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Section 1.3 (K023881)
The 1064 laser system and accessories are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic general surgery, gastroenterology, gynecology, otorhinolarynqology (ENT), neurosurgery, oculoplastic, pulmonarythoracic 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, Venus 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), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verucae, 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 Profile 1064 laser system and accessories is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The Profile 1064 laser system and accessories is indicated for the treatment of facial wrinkles.
The intended use of the contact cooling system in the Profile handpiece is to provide cooling of the skin prior to, during and after laser treatment, for the epidermal protection of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
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.
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Section 1.4 (this application)
The mJOULE 1064 laser systems and accessories is intended for use in the medical special and plastic surgery, dermatology, endoscopic general surgery, gastroenterology, gynecology, otorhinolarynqology (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, verucae, 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.q., 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/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.
| Safety andEffectiveness | The indications for use are based upon the indications for use for predicate systems.Technologically, the mJOULE System is substantially equivalent to the listedpredicate devices. Therefore, the risks and benefits for the mJOULE System iscomparable to the predicate devices. |
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| Summary ofNon-clinicalTests: | Performance: FDA recognized consensus standards were utilized to evaluate themJOULE system for non-clinical performance. These included electrical, mechanicEMC testing, usability and essential performance of the mJOULE system.IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 applicable for thegeneral requirements concerning basic safety and essential performancethat are applicable to medical electrical equipment.Examples of tests performed on the mJOULE system based upon thisstandard 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 thebasic safety and essential performance of medical equipment (ME) in thepresence of electromagnetic disturbance and for electromagnetic emissionof ME systems.Examples of the tests performed are electrostatic discharge immunity test,electromagnetic field immunity, transient immunity, power frequencymagnetic field immunity, voltage dips/interruptions immunity tests, etc. |
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- . 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.
The conclusions drawn from the non-clinical tests demonstrate that the mJOULE Conclusion: system is safe and effective, and performs as well as or better than the legally marketed device predicate.
§ 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.