HELIOS IV 785

• K Number: K212663
• Device Name: HELIOS IV 785
• Manufacturer: Laseroptek Co., Ltd.
• Date Cleared: 2022-06-09 ( 290 days)
• Product Code: GEX
• Regulation Number: 878.4810
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K152856 , K170597

Intended Use

[Indication for use of Q-switched Nd:YAG Laser]

• Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064nm)
• Removal or lightening of unwanted hair with or without adjuvant preparation (1064mm)
• Tattoo Removal (1064nm, 532nm)
• dark ink : blue and black (1064nm)
• · light ink : red, sky blue, green (532nm)
• Treatment of Vascular Lesions (532nm)
• · port wine birthmarks
• · telangiectaias
• · spider angioma
• · cherry angioma
• · spider nevi
• Treatment of Pigmented Lesions (1064nm, 532nm)
• · café-au-lait birthmarks (532nm)
• · solar lentiginos (532nm)
• · senile lentiginos (532nm)
• · becker's nevi (532nm)
• · freckles (532nm)
• · nevus spilus (532nm)
• nevus of ota (1064nm)
  [Indication for use of Ti:Sapphire Laser]
• Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. (785nm)

• O-switched Nd: Y AG Laser and Ti:Sapphire Laser cannot be used simultaneously *

Device Description

HELIOS IV 785 consist of a set of Q-switched Nd: YAG (1064 nm) laser, frequency doubled KTP Nd:YAG (532 nm) laser, and Ti:Sapphire laser (785 nm), and controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.

AI/ML Overview

This is a 510(k) premarket notification for the Laseroptek Co., Ltd. HELIOS IV 785, a laser surgical instrument for use in general and plastic surgery and in dermatology. The document focuses on demonstrating substantial equivalence to predicate devices, rather than an AI-powered device. Therefore, the typical acceptance criteria and study design elements for AI/ML device performance are not applicable or described in this document.

The document does not describe the acceptance criteria and a study that proves a device meets them in the context of an AI/ML algorithm. Instead, it is a Premarket Notification (510(k)) for a medical device (a laser system), demonstrating substantial equivalence to already legally marketed predicate devices.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance for an AI device is not present in this document. The document focuses on the technical characteristics and intended use of the laser system.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

• Not applicable in the context of AI/ML performance. This document describes a laser system. The "performance data" section refers to compliance with safety standards and electrical/mechanical performance, not diagnostic accuracy or AI model performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable. There is no mention of a test set, data (images/signals), or data provenance in the context of an AI/ML algorithm.

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. There is no discussion of ground truth establishment by experts for an AI/ML output.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No test set or adjudication method is described for an AI/ML algorithm.

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 is a hardware device (laser system), not an AI/ML diagnostic or assistive device. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a laser system, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• Not applicable. There is no AI/ML component discussed that would require ground truth.

8. The sample size for the training set:

• Not applicable. No AI/ML training set is mentioned.

9. How the ground truth for the training set was established:

• Not applicable. No AI/ML training set or ground truth process is mentioned.

Summary of what the document does describe (relevant to device performance, but not AI performance):

The document details the technical characteristics of the HELIOS IV 785 laser system and compares them to two predicate devices (Helios III Q-Switched Nd:YAG Laser System and PicoWay Laser System) to demonstrate substantial equivalence.

Performance Data (Non-clinical tests mentioned):

The device underwent non-clinical testing to ensure compliance with various standards related to laser products, general safety, electromagnetic compatibility, usability, and biocompatibility.

• 21 CFR 1040.10 and 1040.11 (mandatory performance standards for laser products)
• IEC 60601-1:2005+A1:2012 (general requirements for basic safety and essential performance)
• IEC 60601-1-2:2014 (electromagnetic disturbances)
• IEC 60601-1-6:2010+AMD1:2013 (usability)
• IEC 60601-2-22:2019 (particular requirements for surgical, cosmetic, therapeutic and diagnostic laser equipment)
• IEC 60825-1:2014 (safety of laser products, classification and requirements)
• ISO 14971:2012 (risk management)
• IEC 62366:2008 (usability engineering)
• ISO 10993-5:2009 and ISO 10993-10:2013 (biocompatibility)

The "reported device performance" in this context is the successful evaluation and compliance with these non-clinical standards, which are considered sufficient to establish substantial equivalence for the safety and effectiveness of the laser device.

Regulation Number and Section

§ 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.