HELIOS 785 Pico

• K Number: K230373
• Device Name: HELIOS 785 Pico
• Manufacturer: Laseroptek Co., Ltd.
• Date Cleared: 2023-05-22 ( 98 days)
• Product Code: GEX
• Regulation Number: 878.4810
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K191685 , K212663

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 (1064nm)
• Tattoo Removal (1064nm, 532nm)
  dark ink : blue and black (1064nm)
  light ink : red, sky blue, green (532nm)
• Treatment of Benign Vascular Lesions (532nm)
  port wine birthmarks
  telangiectaias
  spider angioma
  cherry angioma
  spider nevi
• Treatment of Benign 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)
  Q-switched Nd:YAG Laser and Ti:Sapphire Laser cannot be used simultaneously.

Device Description

HELIOS 785 Pico consists of a Q-switched Nd:YAG (1064 nm) laser, frequency doubled KTP Nd:YAG (532 nm) laser, and Ti:Sapphire laser (785 nm). The device consists of a main body, color touch screen, articulated arm, foot switch and several handpieces, and is controlled by an embedded processor. The device uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis to achieve its intended purpose. It is for prescription use only.

AI/ML Overview

The provided text is a 510(k) Premarket Notification submission for the HELIOS 785 Pico laser device. This document focuses on demonstrating substantial equivalence to existing predicate devices based on technical specifications and non-clinical testing, rather than presenting clinical study data to prove performance against specific acceptance criteria for an AI/software as a medical device (SaMD).

Therefore, the information requested in points 1-9 cannot be fully extracted or inferred from this document. This device is a laser surgical instrument, not an AI/SaMD, and its clearance pathway typically does not involve extensive clinical studies with human readers, ground truth consensus, or the specific types of performance metrics associated with AI algorithms.

Here's a breakdown of why the information is not present and what can be extracted:

Information Not Present in the Document:

• 1. Table of acceptance criteria and reported device performance (in the context of AI/SaMD): This document details technical specifications and non-clinical test validations (e.g., electrical safety, EMC, laser safety standards). It does not present acceptance criteria or performance metrics related to diagnostic accuracy, sensitivity, specificity, or other measures typically used for AI/SaMD.
• 2. Sample size and data provenance for a test set: Not applicable as there's no clinical test set for AI performance. Non-clinical tests were conducted on the device itself.
• 3. Number of experts and qualifications for ground truth: Not applicable.
• 4. Adjudication method: Not applicable.
• 5. Multi-reader multi-case (MRMC) comparative effectiveness study: The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study or effect size for human reader improvement with AI assistance was performed or reported.
• 6. Standalone performance for an algorithm: Not applicable, as this is a hardware laser device, not a standalone algorithm.
• 7. Type of ground truth used: Not applicable.
• 8. Sample size for the training set: Not applicable, as there is no AI algorithm being trained.
• 9. How ground truth for the training set was established: Not applicable.

What can be extracted or inferred from the document:

• Device Type: Laser Surgical Instrument (specifically, a combination of Q-switched Nd:YAG and Ti:Sapphire lasers).
• Regulatory Class: Class II (Product Code: GEX).
• Indications for Use: Detailed for both Q-switched Nd:YAG Laser (incision, excision, ablation, vaporization of soft tissue; hair removal; tattoo removal of various colors; treatment of benign vascular lesions; treatment of benign pigmented lesions) and Ti:Sapphire Laser (removal of green and blue tattoos for Fitzpatrick skin types II-IV).
• Comparison to Predicate Devices: The submission is based on demonstrating substantial equivalence to the HELIOS IV 785 (K212663) as the primary predicate and PicoWay Laser System (K191685) as a reference predicate.
• Non-Clinical Testing: The document lists various non-clinical tests conducted to verify the device conforms to relevant mandatory performance standards and design specifications. These include:
  • IEC 60601-1:2005/A1:2012 (Medical Electrical Equipment General Requirements)
  • IEC 60601-1-2:2014 (Electromagnetic Compatibility)
  • IEC 60601-2-22:2012 (Specific Requirements for Laser Equipment)
  • IEC 60825-1: 2014 (Safety of laser products - Part 1: Equipment classification and requirements)
  • Biocompatibility evaluation per ISO 10993 and FDA guidance
  • Usability per IEC 60601-1-6 and IEC 62366
  • Risk management per ISO 14971
  • Software Validation & Verification Test
  • Bench Testing to verify the performance.
• No Clinical Study: The document explicitly states, "No clinical study is included in this submission." This indicates that the substantial equivalence determination for this device relies primarily on the demonstrated technical equivalence and non-clinical testing results, rather than clinical efficacy studies.

In summary, the provided document is a regulatory submission for a physical medical device (laser), not an AI/SaMD. Therefore, it does not contain the information typically associated with the acceptance criteria and study designs for proving AI device performance.

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.