(84 days)
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No
The summary describes a laser surgical device and its components, focusing on the mechanical and optical aspects of its operation. There is no mention of AI, ML, image processing for analysis, or any data-driven decision-making processes within the device's description or performance studies.
No
The device is a surgical laser used for creating corneal flaps, which is a surgical tool, not a therapeutic device designed to treat a medical condition.
No
The device is described as a surgical laser used to create a corneal flap for LASIK or other lamellar resection treatments, indicating a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including a laser unit, handpiece, base station, and accessories, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. They are used outside the body.
- Device Function: The Da Vinci™ Femtosecond Surgical Laser is a surgical device used directly on the patient's eye (specifically the cornea) to perform a surgical procedure (creating a corneal flap). It does not analyze samples taken from the body.
The information provided clearly describes a surgical laser used for a procedure performed in vivo (within the living body), not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Da Vinci™ Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
Product codes
GEX, HNO
Device Description
The Da Vinci™ Femtosecond Surgical Laser is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections. The cutting action of the Da Vinci™ Femtosecond Surgical Laser is achieved through nonlinear absorption of infrared laser light and subsequent disintegration of tissue, created by focused ultrashort pulses which are delivered through a lens while fixating the eye under a vacuum.
The complete Da Vinci™ Femtosecond Surgical Laser system consists of the following functional units:
-
- Base Station (BS), integrating the Laser Unit, Fast Scan Unit (FS), and Fixed Mirror Articulating Arm (FMAA)
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- Handpiece (HP), integrating the Slow Scan Unit (SS) and the Cutting Lens
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- Accessories, comprising Suction Ring, Distance Foil, Vacuum Tube with Strainer and Handpiece Cover
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
corneal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/0 description: The image shows a handwritten alphanumeric string. The string appears to be "K0535//". The characters are written in a simple, slightly irregular style, suggesting they were written quickly or casually. The writing is dark and clear against a lighter background.
510(k) Summary for the Femtosecond Laser Microkeratome
Device trade name: Da Vinci™ Femtosecond Surgical Laser
Common/Classification name: Ophthalmic Surgical Laser
Establishment Name: SIE LTD. SURGICAL INSTRUMENT ENGINEERING Allmendstr. 11 Port/Biel, SWITZERLAND 2562
Registration Number: Pending Registration
Regulatory Class: Class I
Classification Name: Ophthalmic Laser
Regulation Number: 21 CFR 878.4810, 886.4370
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Product Code: GEX, HNO
Reviewing Panel: Ophthalmic Devices
indications for Use: The Da Vinci™ Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
Performance Standards: The Da Vinci™ Femtosecond Surgical Laser is in full compliance with FDA's Performance Standard for Light-emitting Products; 21 CFR §1040.10 and 1040.11.
Device Description: The Da Vinci™ Femtosecond Surgical Laser is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections. The cutting action of the Da Vinci™ Femtosecond Surgical Laser is achieved through nonlinear absorption of infrared laser light and subsequent disintegration of tissue, created by focused ultrashort pulses which are delivered through a lens while fixating the eye under a vacuum.
The complete Da Vinci™ Femtosecond Surgical Laser system consists of the following functional units:
-
- Base Station (BS), integrating the Laser Unit, Fast Scan Unit (FS), and Fixed Mirror Articulating Arm (FMAA)
-
- Handpiece (HP), integrating the Slow Scan Unit (SS) and the Cutting Lens
-
- Accessories, comprising Suction Ring, Distance Foil, Vacuum Tube with Strainer and Handpiece Cover
1
The Da Vinci™ Femtosecond Surgical Laser is movable on four rollers. Two rollers can be locked by a mechanical brake. For movement inside the clinic, HP and FMAA can be locked in a secured transport position.
Base Station
The Base Station is in a position perpendicular to the patient's body axis, allowing manipulation of the FMAA from both sides of the BS. The Base Station is height adjustable in a way as to allow positioning of the shoulder (middle) joint at 950–1250mm above ground. This allows the adjustment of the system to different types of patient couches and Excimer lasers within a range of 300mm. The nominal reference height is 1000mm.
On the table of the Base Station there is park position where HP and forearm of the FMAA are locked when the system is not in operation. In this park position the accessories, i.e. the distances foil DF, the suction ring SR and the vacuum tubing can be mounted comfortably.
The Da Vinci™ Femtosecond Surgical Laser has a protective housing that prevents unintentional access to laser radiation.
Fixed mirror articulating arm
The FMAA consists of two arm elements (upper and lower arm) and three joints (shoulder, elbow and hand) connecting the HP to the BS. Thus, the HP can easily be moved by the user in all 6 degrees of freedom of the space.
The FMAA is balanced in a way as to hold the residual net force, i.e., without external force on HP or of FMAA on eye, at