(30 days)
The InMode Multi System with the Diode laser Applicators is indicated for:
· Diolaze XL 810nm Applicator is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime.
· Diolaze XL 755/810nm & 810/1064nm Applicators are intended for hair removal.
· VLaze Applicator is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.
The InMode Multi System with the IPL Applicator is indicated for:
• IPL Applicator with wavelengths (515-1200mm) is indicated for use for the following treatments: The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikilodenna of Civatte, superficial leg veins and venlous malformations.
The InMode Multi System with the non-invasive RF Applicators is indicated for:
· BodyFX (WMBody) and MiniFX Applicators are intended for the tollowing medical conditions: Relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation; and temporary reduction in the appearance of cellulite.
· PLUS/ PLUS90/PLUS-PLUS (FORMA) and i-Forma Applicators are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
· FaceFX (WMFace) Applicator is intended for use in dermatologic procedures, for noninvasive treatment of mild to moderate facial wrinkles and rhytids.
The InMode Multi System with the Fractional RF Applicators is indicated for:
· FRACTORA 60 pin Applicator is intended for use in dermatological procedures requiring ablation and resurfacing of the skin.
· FRF 24 pin Applicator is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
· Fractora3D and Morpheus8 Applicators are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 mJ/pin, use is limited to Skin Types I-V.
The InMode Multi-System supports multiple technological applications and accessories intended for different clinical indications. The subject device is designed to exert finely controlled radiofrequency, laser or IPL energy utilizing different treatment applicators. The subject device comprises a system platform and compatible set of applicators. The system platform was originally FDA Cleared in K180719 and is manufactured by InMode Ltd.
The subject device platform sustains additional FDA Cleared applicators, all manufactured by InMode Ltd.
The below list comprises the set of applicators to be registered under the subject device:
- . Laser Applicators:
- o Diolaze XL 810nm
- Diolaze XL 755/810nm o
- Diolaze XL 810/1064nm o
- VLaze (Vasculaze) о
- IPL Applicator: ●
- o SR IPL (Lumecca 580, Lumecca 515)
- Non-Invasive RF Applicators: ●
- o Forma (Plus)
- Plus (Plus Plus) о
- Plus90 o
- о i-Forma
- BodyFX™ (WMBody) o
- MiniFXTM o
- WMFace o
- Fractional RF Applicators: ●
- Fractora o
- 24 pins tip (FRF) -
- । 60 pins tip
- 0 Morpheus8TM
- 12 pins tip (Prime Tip) -
- 24 pins tip (Fractora 3D) -
- 40 pins tip (Body Tip) -
- T tip -
- Fractora o
The platform of the subject device has undergone some slight design modifications, mainly in software, to support the integration of the abovementioned applicators.
Slight modifications were also performed on platform hardware for the same purpose.
Additionally, the user interface screen was slightly enlarged from 10" to 12".
This document describes an FDA 510(k) premarket notification for the InMode Multi-system, a medical device with various applicators for dermatological and general surgical procedures. The submission claims substantial equivalence to previously cleared predicate devices.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity, specificity, or metrics for effectiveness. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices. This means that the device is shown to be as safe and effective as a legally marketed device that does not require premarket approval.
The reported device performance is broadly stated as maintaining the same safety and effectiveness as the predicate devices:
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Safety (Electrical, Mechanical, Thermal, Radiation) | Complies with recognized consensus standards (e.g., ANSI AAMI ES 60601-1, IEC 60601-1-6, IEC 60601-1-2, IEC 60601-2-2, IEC 60825-1, IEC 60601-2-22, IEC 60601-2-57). "The safety features and compliance with safety standards of the InMode Multi system are identical to the safety features and compliance with safety standards of the predicate devices." |
| Effectiveness (Clinical Indications) | "The indications for use and technological characteristics of the InMode Multi system (subject device) are substantially equivalent to the indications for use and technological characteristics of the InMode system (primary predicate device) and of the applicators predicate devices (secondary predicate devices)." |
| Biocompatibility | "All of the modified device materials which come in direct contact with the patient skin are biocompatible and identical to the materials used in the manufacturing of the predicate devices." |
| Performance Specifications | "Both the subject and predicate devices present identical performance specifications (for the specified indications for use) and identical monitoring features (where applicable) in order to maintain the desired performance specifications." (See detailed specifications in tables in prompt) |
| Technological Characteristics | "The subject device applicators possess identical technological principals to that of the predicate devices' applicators." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states:
- Non-Clinical (Bench) Performance Data: Not Applicable
- Animal Performance Data / Histology Data: Not Applicable
- Clinical Performance Data: Not Applicable
Therefore, there is no mention of a test set, sample size, or data provenance from clinical studies for this 510(k) submission. The device's substantial equivalence is based on engineering comparisons and compliance with recognized standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical performance data or test set was used for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical performance data or test set was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI-assisted diagnostic or interpretation tool; it is a physical device (laser, IPL, RF system) for treatments. No MRMC study was mentioned or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical performance data was used for this submission. The "ground truth" for demonstrating substantial equivalence relies on the established safety and effectiveness of the predicate devices and the technical comparison performed.
8. The sample size for the training set
Not applicable, as no AI/machine learning model is being described or used in a way that requires a training set for this 510(k) submission.
9. How the ground truth for the training set was established
Not applicable, as no AI/machine learning model is being described.
§ 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.