(56 days)
The EVO Platform is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.
Indications for use
1064 & 532 nm (Q-Switched, nanosecond mode)
The EVO Platform is intended for treatment of vascular lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:
532 nm (Q-Switched, nanosecond mode)
Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
Treatment of vascular lesions including, but not limited to:
- port wine birthmarks
- telangiectasias
- spider angiomaa
- Cherry angioma
- Spider nevi
Treatment of benign pigmented lesions including, but not limited to:
- cafe-au-Iait birthmarks
- Ephalides, solar lentigines
- senile lentigines
- Becker's nevi
- freckles
- common nevi
- nevus spilus
- Ota Nevus
Treatment of seborrheic keratosis
Treatment of post inflammatory hyperpigmentation
Skin resurfacing procedures for the treatment of acne scars and wrinkles.
1064 nm (O-Switched, nanosecond mode)
Removal of dark ink (black, blue and brown) tattoos
Removal of benign pigmented lesions including;
- nevus of Ota
- Café au lait spot
- Ephalides, solar lentigo (lentigines)
- Becker Nevus
- Nevus spilus
Treatment of common nevi
Removal or lightening of unwanted hair
Skin resurfacing procedures for the treatment of acne scars and wrinkles
1064 nm (non Q-Switched - free running mode)
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.
Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to port wine stains,
hemaongiomae, warts, telangiectasiae, 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.
532 nm (picosecond mode)
Indicated for the removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.
1064 nm (picosecond mode)
Indicated for the removal of tattoos for all skin types (Fitzpatrick skin types I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.
1064 nm (pulsed)
Dermatology/Plastic Surgery:
Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis.
The laser is also intended for the treatment of benign pigmented lessons such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. The laser is also indicated for the treatment of facial wrinkles.
Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The laser is also indicated for pigmented lesions to reduce lesion size, for patients with lessions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
It is indicated for use on all skin types (Fitzpatrick I-VI ) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.
532 nm (pulsed)
Intended for the coagulation and hemostasis of vascular lesions.
Dermatology/Plastic Surgery:
For photocoagulation and hemostasis of vascular and cutaneous lesions in dermatology including but not limited to the following general categories: vascular lesions [angiomas (port wine), telangiectasia (facial or ex-tremities telangiectasias, venous anomalies, leg veins]; benign pigmented lesions (nevi, lentigines, chloasma, cafe au- lait, tattoos (red and green ink), verrucae, skin tags, keratoses, plaques, cutaneous lesion treatment (hemostasis, color lightening,
blanching, flattening, reduction of lesion size).
694 nm (Q-Switched)
Indicated for:
Tattoo removal: Suggested for blue, sky blue, black, green and violet ink
- Pigmented lesion removal (benign):
- Cafe au lait spot
- Ephalides, solar lentigo lentigines)
- Becker Nevus
- Ota and Ito Nevus
- Nevus spilus
- Mongolian spot
694 nm (non q-switch - free running mode)
Intended to remove benign dermal and epidermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.
755 nm (pulsed)
Indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
1320 nm (pulsed)
Indicated for use in general surgery and dermatology for the incision, ablation, vaporization, coagulation and haemostasis of soft tissue. It is also indicated for the treatment of perioral wrinkles, fine lines and wrinkles, and the treatment of back acne and atrophic acne scars.
IPL 590-1200nm; 625-1200nm; 650-1200nm
Indicated for permanent hair removal.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime
IPL 550-1200nm; 570-1200nm
Indicated for photocoagulation of dermatological vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.
IPL 400-1200nm
Indicated for inflammatory acne (acne vulgaris).
Integrated Skin Cooler
The intended use of the integrated cooling system in the EVO Platform is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments.
The EVO Platform is a laser family that includes Q-Switched and/or Pulsed laser sources, emitting at one or more of the following wavelengths: 532 nm, 1064 nm, 1320 nm (Nd:YAG laser), 694 nm (Ruby laser), or 755 nm (Alexandrite laser).
The EVO Platform systems, through the special universal Twain connector, can be equipped with intense pulsed light handpieces (Twain IPL) emitting at the following wavelengths: 650-1200nm, 625-1200nm, 590-1200nm, 570-1200nm, 550-1200nm, 400-1200nm.
The EVO Platform systems, when operating with Pulsed laser sources and IPL, can be used in combination with optional contact, or air, cooling systems.
The optical delivery system is an articulated arm with fixed handpieces for Q-switched sources and an optical fiber with focusing handpieces for pulsed sources. The optical delivery system for the IPL system is a handpiece (Twain IPL) with fixed or interchangeable light filters at different wavelengths.
All the models belonging to the EVO platform have the same components and the same control software. The only difference between different models is the optical bench that depends on the sources installed.
The EVO Platform is controlled via a touch screen display housed in the front of the device.
Emission is triggered by means of a footswitch.
This document is a 510(k) Special Summary for a medical device called the EVO Platform, which is a laser system used in various aesthetic, cosmetic, and surgical applications. The submission is for modifications to an already cleared device, focusing on changes to performance specifications.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Strictly speaking, the document does not present a table of "acceptance criteria" in the typical sense of specific, quantitative thresholds for a diagnostic AI device (e.g., sensitivity, specificity, AUC). Instead, it describes general compliance with recognized consensus standards.
The acceptance criteria here are implicitly:
- Compliance with safety and performance standards: The device must meet the requirements of specific IEC standards for medical electrical equipment and laser safety.
- Software verification and validation: The software must be verified and validated according to FDA guidance.
- Biocompatibility: Materials must be biocompatible.
The reported device performance is that the modified device "passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards."
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Safety & Essential Performance | IEC 60601-2-22 (Surgical Laser Equipment) | Passed all required testing; in compliance. |
| Laser Safety | IEC 60825-1 (Laser Product Classification & Requirements) | Passed all required testing; in compliance. |
| General Safety & Performance | IEC 60601-1 (Medical Electrical Equipment) | In compliance (both modified and unmodified devices). |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 (Collateral Standard: EMC) | In compliance (both modified and unmodified devices). |
| Software | FDA Guidance for Software Contained in Medical Devices | Software verification and validation conducted; documentation provided. |
| Biocompatibility | Established based on predicate devices. | Materials have no differences from predicate; biocompatibility established. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a device modification to a laser system, not an AI software intended for diagnosis or prediction using a dataset of images or other patient data. Therefore, the concept of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) as it applies to AI/machine learning models is not applicable here. The "testing" refers to physical device performance and safety testing against engineering standards.
3. Number of Experts Used to Establish Ground Truth
Again, this is not applicable as the document concerns a physical laser device modification, not an AI diagnostic algorithm requiring expert-established ground truth from medical images or patient data. The "ground truth" for this device is compliance with engineering and safety standards.
4. Adjudication Method
Not applicable for the same reasons as above. There is no human adjudication of diagnostic findings described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This study type is highly relevant for evaluating AI tools that assist human readers in tasks like image interpretation. This document describes a laser device; it does not involve human readers interpreting cases with or without AI assistance.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This document is for a physical laser device. The "software" mentioned underwent verification and validation, but not in the sense of a standalone diagnostic algorithm being evaluated for performance on a dataset.
7. Type of Ground Truth Used
The "ground truth" for this device is its adherence to engineering specifications, safety standards (e.g., IEC 60601 series, IEC 60825-1), and FDA guidance for software verification and validation. There is no clinical "ground truth" (like pathology, expert consensus, or outcomes data) in the context of diagnostic accuracy assessment because the device is a therapeutic/surgical tool, not a diagnostic one.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning model that undergoes "training" on a dataset. The software mentioned is likely embedded control software, verified and validated through traditional software engineering methods, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reasons as in point 8.
§ 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.