← Product Code [HRN](/submissions/OP/subpart-e%E2%80%94surgical-devices/HRN) · K062412 # CRYOMATIC (K062412) _Keeler Instruments, Inc. · HRN · Nov 6, 2006 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HRN/K062412 ## Device Facts - **Applicant:** Keeler Instruments, Inc. - **Product Code:** [HRN](/submissions/OP/subpart-e%E2%80%94surgical-devices/HRN.md) - **Decision Date:** Nov 6, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.4170 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic - **Attributes:** Therapeutic, Pediatric ## Intended Use The Keeler Cryomatic System and probes are for use in ophthalmic surgery in cryopexy procedures in retinal detachment, cataract extraction, cryo destruction of lash follicles, treatment of retinopathy of prematurity (ROP), and procedures in refractory glaucoma, extraction of fragments within the eye. ## Device Story Cryomatic System consists of console and probes; used in ophthalmic surgery. Device utilizes cryogenic technology to perform cryopexy, cataract extraction, and tissue destruction. Operated by ophthalmologists in clinical/surgical settings. Console controls gas flow to probes to achieve localized freezing temperatures for therapeutic tissue destruction or adhesion. Benefits include precise, controlled application of cold for various ophthalmic procedures. Output is physical cooling of probe tip applied directly to ocular tissue. ## Clinical Evidence No clinical data provided; substantial equivalence based on design and technological similarity to legally marketed predicate devices. ## Technological Characteristics Cryogenic surgical system; console-based gas delivery to specialized probes. Class II device (21 CFR 886.4170). ## Regulatory Identification A cryophthalmic unit is a device that is a probe with a small tip that becomes extremely cold through the controlled use of a refrigerant or gas. The device may be AC-powered. The device is intended to remove cataracts by the formation of an adherent ice ball in the lens, to freeze the eye and adjunct parts for surgical removal of scars, and to freeze tumors. ## Predicate Devices - Keeler Cryomaster and Probes ([K992954](/device/K992954.md)) - Keeler ACU 22 XT Ophthalmic Cryo unit ([K874555](/device/K874555.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # K062412 ## 510 (k) Summary Section 3 February 23rd 2006 NUW - 6 2006 #### 1 Submitter Keeler Instruments Inc 456 Parkway Broomall PA. 19008 USA. Contact: Mr. Eugene r. Van Arsdale Marketing Manager Tel: 001 610 353 4350 Fax: 001 610 353 7814 E.Mail: erv@keelerusa.com #### 2 Name of Device Proprietary Name: Cryomatic System and Probes comprising of: - a) Cryomatic Console - b) Cryomatic Probes Common Name - Ophthalmic Cryo. Systems and Probes Device Classification: Cryogenic Surgical devices have been placed in Class II as per 21 CFR Regulation Number 886.4170 and assigned the Product Code 86HRN #### 3 Predicate Devices The components of the Cryomatic System are substantially equivalent to the following legally marketed devices: - K992954 Keeler Cryomaster and Probes K874555 Keeler ACU 22 XT Ophthalmic Cryo unit. This statement is based on the similarity of the subject device to the predicate devices in intended use, materials, design and principles of operation. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by three abstract, wave-like lines, and the text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV - 6 2006 Keeler Instruments Inc. c/o Mr. Eugene R. Van Arsdale 456 Parkway Broomall, PA 19008 Re: K062412 Tradc/Device Name: Cryomatic System & Probes Regulation Number: 21 CFR 886.4170 Regulation Name: Cryophthalmic unit Regulatory Class: II Product Code: HRN Dated: October 18, 2006 Received: October 20, 2006 Dear Mr. Van Arsdale: 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 intestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federal Fiond, Or to and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA), 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbrandi, ing 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, TDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination docs 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 seg forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1000, {2}------------------------------------------------ ### Page 2 - Mr. Eugene R. Van Arsdale 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. Egelston MD Malvina B. Fydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Indications for Use Page 1 of 1 KO62412 510(k) Number (if known): Device Name: Cryomatic System & Probes Indications for Use: The Keeler Cryomatic System and probes are for use in ophthalmic surgery in cryopexy The Reeler Cryoniatic Bystem and procedures in refractory glaucoma, extraction of for remal detachinent, eyello destruction, cataract extraction, cryo destruction of lash follicles fragments within treatment of retinopathy of prematurity (ROP) Prescription Use (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) Marsha L. Dimple Nicholas (Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises 510(k) Number K062412 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HRN/K062412](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HRN/K062412) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com