(136 days)
Not Found
No
The summary describes a laser keratome for corneal flap creation and does not mention any AI or ML components or functionalities.
Yes
The device is used in LASIK surgery or other treatments requiring lamellar resection of the cornea, which are therapeutic procedures.
No
The device description clearly states it is a "precision ophthalmic surgical laser designed for use in performing lamellar corneal resections," indicating its purpose is for surgical intervention, not diagnosis. The "Intended Use" also confirms its role in creating a corneal flap for LASIK surgery, which is a treatment procedure.
No
The device description clearly states it is a "precision ophthalmic surgical laser" and describes its cutting action through "ultrashort pulses delivered through a disposable applanation lens," indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Horus Laser Keratome Function: The Horus Laser Keratome is a surgical device used directly on the patient's eye to create a corneal flap. It performs a physical action (lamellar resection) on living tissue within the body.
The description clearly indicates a surgical tool used for a procedure on a patient, not a device used to analyze samples in a lab.
N/A
Intended Use / Indications for Use
The Horus Laser Keratome is 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 Horus Laser Keratome is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections. The cutting action of the Horus Laser Keratome is achieved through precise individual mirco-photodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vaccum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cornea
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
Not Found
Summary of Performance Studies
The Horus Laser Keratome was found to perform equivalently to the predicate device, the Hansatome Microkeratome, with respect to the creation of cornea resections in extensive ex-vivo studies.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
5. 510 (K) SUMMARY
K062314
510 (k) SUMMARY (per 21 CFR §807.92)
HORUS Laser Keratome
GENERAL INFORMATION
Manufacturer: Carl Zeiss Meditec AG Göschwitzer Strasse 51-52 07740 Jena Germany Est. Reg. No. 9615030 Contact Person: Michael Giebe RA-Manager U.S. Designated Agent: Kent W. Jones Vice President, RA/CA/Compliance Carl Zeiss Meditec Inc. 5160 Hacienda Drive Dublin, California 94568 (925) 557-4353 (phone) (925) 557-4481 (fax) Classification name: Keratome Classification: Class II (acc. 21 CFR 878.4810) Product Code: GEX (21 CFR 878.4810) HNO (21 CFR 886.4370) Trade/Proprietary name: Horus PREDICATE DEVICE
| Company: | IntraLase Corporation |
|---|---|
| Device: | IntraLase FS Laser (K013941) |
| Company: | Bausch & Lomb Surgical |
| Device: | Hansatome Microkeratome (K010260) |
DEC 2 2 2006
1
INTENDED USE
The Horus Laser Keratome is 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.
DEVICE DESCRIPTION
The Horus Laser Keratome is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections. The cutting action of the Horus Laser Keratome is achieved through precise individual mirco-photodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vaccum.
SUBSTANTIAL EQUIVALENCE
The Horus Laser Keratome has technological characteristics very similar to those of the IntraLase FS Laser, the laser predicate device, while the indication for use and the intended use are identical to those of the Hansatome Microkeratome.
SUMMARY
The Horus Laser Keratome has been designed and tested to applicable safety standards. In addition, the Horus Laser Keratome was found to perform equivalently to the predicate device, the Hansatome Microkeratome, with respect to the creation of cornea resections in extensive ex-vivo studies.
A statement of substantially equivalence to another product is required by 21 CFR 807.87 and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the commissioner of the FDA stated: "A determination of substantial equivalence under the Federal Food, Drug and Cosmetic Act related to the fact that the product can be lawfully marketed without pre-market approval or reclassification. The determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Federal Register 42, 50 et seq. (1977).
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three wavy lines, which are meant to represent the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 2006
Carl Zeiss Meditec, Inc. c/o Kent Jones 5160 Hacienda Drive Dublin, CA 94568
Re: K062314
Trade/Device Name: Horus Laser Keratome Regulation Number: 21 CFR 878.4310 Regulation Name: Laser Instrument, Surgical, Powered Regulatory Class: Class II Product Codes: GEX; HNO Dated: December 21, 2006 Received: December 22, 2006
Dear Mr. Jones:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M B Eychlmu Si WD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4.
4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Ko6 2314
Device Name:
Horus Laser Keratome
Indications for Use:
The Horus Laser Keratome is 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
ision of Ophthalmic Ea e and Throat Devis
510(k) Number
Prescription Use (Per 21 CFR 801.109)
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