(31 days)
VISULAS YAG IIplusTM (1)
Not Found
No
The summary describes a laser device with specific technical parameters (wavelength, beam diameter, pulse length, energy output) and intended uses. There is no mention of AI, ML, image processing, training sets, test sets, or performance metrics typically associated with AI/ML devices. The predicate device is also a laser, further suggesting a non-AI/ML technology.
Yes
The device is described as a laser used for ophthalmic applications (posterior capsulotomy and peripheral iridotomy), which are medical procedures aimed at treating conditions. Therefore, it is a therapeutic device.
No
The device is described as a laser for ophthalmic applications such as posterior capsulotomy and peripheral iridotomy, which are therapeutic procedures, not diagnostic ones. There is no mention of the device being used to detect, prevent, or monitor a disease.
No
The device description explicitly states it is a Neodymium : Yttrium : Garnet (Nd: YAG) laser, which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for ophthalmic applications (posterior capsulotomy and peripheral iridotomy) using a laser. This is a therapeutic procedure performed directly on the patient's eye.
- Device Description: The device is a laser (Nd: YAG laser) used for surgical procedures.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
Therefore, the VISULAS YAG III™ is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device will be used in ophthalmic applications, including posterior capsulotomy and peripheral iridotomy. This device is intended for use primarily by physicians and health care workers and may only be used under the supervision of a physician. This device will not be sold to the general public.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The VISULAS YAG III™is a Neodymium : Yttrium : Garnet (Nd: YAG) laser for ophthalmic applications, including posterior capsulotomy and peripheral iridotomy. The device operates at a wavelength of 1064 nm. The beam diameter is 10 um with a pulse length of
§ 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.
0
510(k) Summary Carl Zeiss Meditec AG VISULAS YAG III™
K 042139
This 510(k) summary for the VISULAS YAG III is submitted in accordance with the requirements of SMDA 1990 and 21 C.F.R § 807.92.
GENERAL INFORMATION
| Manufacturer: | Carl Zeiss Meditec AG
Carl-Zeiss-Promenade 10
07740 Jena
Germany
Est. Reg. No. 9615030 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael Giebe
Manager - Regulatory Affairs |
| U.S. Agent: | R. Michael Crompton
Vice President, Regulatory/Clinical Affairs
& Quality Assurance
5160 Hacienda Drive
Dublin, California 94568
(925) 557-4353 (phone)
(925) 557-4481 (fax) |
DEVICE DESCRIPTION
| Classification: | Class II |
|---|---|
| Trade Name: | VISULAS YAG III™ |
| Generic/Common Name: | Laser Instrument, Surgical, Powered (21 CFR § 878.4810) |
PREDICATE DEVICE
- VISULAS YAG IIplusTM (1)
INTENDED USE
This device will be used in ophthalmic applications, including posterior capsulotomy and Filis device will or a so a other is intended for use primarily by physicians and health care perfineral may only be used under the supervision of a physician. This device will not be sold to the general public.
1
DEVICE DESCRIPTION
The VISULAS YAG III™is a Neodymium : Yttrium : Garnet (Nd: YAG) laser for ophthalmic applications, including posterior capsulotomy and peripheral iridotomy. The device operates at a wavelength of 1064 nm. The beam diameter is 10 um with a pulse length of