FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

· Excisional and incisional biopsies
· Exposure of unerupted teeth
Fibroma removal
· Gingivoplasty
· Hemostasis and coagulation
· Incision and drainage of abscess
· Operculectomy
· Pulpotomy
· Reduction of gingival hypertrophy
· Soft tissue crown lengthening
· Vestibuloplasty
· Laser Soft Tissue Curettage
· Tissue retraction
Frenectomy and Frenotomy
· Gingival troughing for crown impressions
· Gingivectomy
· Gingival incision and excision
· Implant recovery
· Leukoplakia
· Oral papillectomnies
Pulpotomy as an adjunct to root canal therapy
· Reduction of bacterial level (decontamination) and inflammation
Treatment of aphthous ulcers
· Lesion (tumor) removal
· Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
· Removal of Diseased, Inflamed and necrotic soft tissue within the periodontal pocket
Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium

· Sulcular debridement (removal of necrotic, diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)

· Light activation for bleaching materials for teeth whitening
· Laser-assisted whitening/bleaching of teeth

Device Description

The ELUMI 810 + 980 Soft Tissue Laser, or ELUMI, is a battery-powered counter top surgical and therapeutic device designed for a wide variety of oral soft tissue procedures and dental teeth whitening.

The ELUMI comprises of five main assemblies; of a Laser Unit, a flexible fiber delivery system tethered to an anodized aluminum hand piece, disposable single-use fiber tips, a wireless footswitch, and an auxiliary power supply. Infrared laser energy is emitted from the fiber tips when the wireless footswitch is depressed. The ELUMI Laser Unit contains two single-emitter solid-state laser diodes of 10.0-watt peak output power each (Class IV laser), one lasing at 810nm and the other at 980nm wavelength. The laser diodes can simultaneously emit laser energy when ELUMI is set to Dual Wavelength mode. The laser diodes are directly coupled to the flexible fiber optic cable that connects the Laser Unit to the surgical hand piece and disposable fiber tip that emits the energy to the target area. The system also contains a 5mW power, 650nm laser diode coupled to the same fiber optic cable to produce the red aiming light. The laser's visible light is designed to aid the clinician in aiming the tip of the delivery fiber onto the target tissue. Additionally, a bright white light from two LEDs in the hand piece illuminates tarqet tissue during procedures through the translucent disposable laser tips. The auxiliary power supply connects to the Laser Unit and is used to charge the system battery and as a power source for the system in the event of low battery capacity.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ELUMI 810 + 980 Soft Tissue Laser, claiming substantial equivalence to a predicate device, the QuickLase DUAL+. As such, the study performed is a comparative effectiveness study against a predicate device rather than a standalone study establishing de novo acceptance criteria and performance thresholds.

The primary goal of the submission is to demonstrate that the new device is "as safe and as effective" as the predicate device. Therefore, the "acceptance criteria" can be implicitly understood as showing comparable performance to the predicate device in key functional and safety aspects.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission seeking substantial equivalence to a predicate device, the "acceptance criteria" are generally based on meeting or demonstrating comparable performance to the legally marketed predicate device (QuickLase DUAL+) and compliance with relevant international standards. The performance reported focuses on demonstrating this equivalence.

Acceptance Criteria (Implicit)	Reported Device Performance (ELUMI 810 + 980 Soft Tissue Laser)
Safety:
Adherence to Laser Safety Standards	Complied with 21 CFR 1040.10 & 1040.11 (except for deviations per laser notice 50), IEC 60601-2-22, and IEC 60825-1.
Adherence to Electrical Safety Standards	Complied with AAMI/ANSI ES60601-1 and IEC 60601-1-2.
Biocompatibility	Complied with AAMI/ANSI/ISO 10993-5:2009 (cytotoxicity).
Cleaning Validation (for reusable components)	Anodized Aluminum Surgical Hand Piece with Fiber Connector achieved 78.5% and 77.6% recoveries for protein and hemoglobin respectively. Cleaned devices contained

Summary

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.