← Product Code [MSS](/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS) · K073586 # MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM (K073586) _Staar Surgical Co. · MSS · Mar 13, 2008 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K073586 ## Device Facts - **Applicant:** Staar Surgical Co. - **Product Code:** [MSS](/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS.md) - **Decision Date:** Mar 13, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.4300 - **Device Class:** Class 1 - **Review Panel:** Ophthalmic - **Attributes:** Therapeutic ## Intended Use The MicroSTAAR ™ Indigo Injector Foam Tip System is a device intended to fold and insert STAAR Surgical one and three piece Collamer® lenses for surgical placement in the human eye. ## Device Story MicroSTAAR™ Indigo Injector Foam Tip System is a surgical instrument used by ophthalmologists to fold and insert Collamer® intraocular lenses into the human eye during cataract or refractive surgery. The device facilitates the delivery of the lens through a small incision. It is a mechanical system designed for manual operation by a surgeon. It does not involve electronic components, software, or automated processing. ## Clinical Evidence Bench testing only. ## Technological Characteristics Mechanical intraocular lens insertion system. Consists of a foam tip component designed to interface with STAAR Surgical Collamer® lenses. Non-powered, manual surgical instrument. ## Regulatory Identification An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed. ## 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}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## MAR 1 3 2008 STAAR Surgical Co. C/o Ms. Diana Smith Director of Regulatory Affairs 1911 Walker Avenue, Monrovia, CA 91016 Re: K073586 Trade Name: MicroSTAAR™ Indigo Injector Foam Tip System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I (reserved) Product Code: MSS Dated: February 14, 2008 Received: February 19, 2008 Dear Ms. Smith: 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. {1}------------------------------------------------ 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours. Malvina B. Edwards, and Malvina B. Evdelman. M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Page 3 - Ms. Smith ## Indications for Use 510(k) Number (if known): K0703586 Device Name: MicroSTAAR™ Indigo Injector Foam Tip System Indications For Use: The MicroSTAAR ™ Indigo Injector Foam Tip System is a device intended to fold and insert STAAR Surgical one and three piece Collamer® lenses for surgical placement in the human eye. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) AZ Division Sign-Off (Division Sign Only, Division of Ophthalmic Ear, Nose and Throat Devices 510(k) Number K0130 Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K073586](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K073586) **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