Who is the manufacturer of ASICO SOFTIP INJECTOR SYSTEM?

Asico, LLC filed the 510(k) submission for ASICO SOFTIP INJECTOR SYSTEM (K103495).

What is the FDA product code for ASICO SOFTIP INJECTOR SYSTEM?

MSS. It is classified under 21 CFR 886.4300 as a Class 1 device in the Ophthalmic panel.

What is the regulatory pathway for ASICO SOFTIP INJECTOR SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ASICO SOFTIP INJECTOR SYSTEM?

MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE (K040837); NAVIJECT SUB2-1P, MODEL: LP604430 (K092023); LENSTEC LC INJECTION SYSTEM (K063802).

Who can help prepare an FDA 510(k) submission like ASICO SOFTIP INJECTOR SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ASICO SOFTIP INJECTOR SYSTEM

K103495 · Asico, LLC · MSS · Jun 29, 2011 · Ophthalmic

Device Facts

Record ID	K103495
Device Name	ASICO SOFTIP INJECTOR SYSTEM
Applicant	Asico, LLC
Product Code	MSS · Ophthalmic
Decision Date	Jun 29, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.4300
Device Class	Class 1
Attributes	3rd-Party Reviewed

Intended Use

The ASICO SofTip Injector system is a sterile, single use device intended to insert a foldable intraocular lens through a surgical procedure in a Human eye. The system provides a tubular pathway through a incision, allowing the delivery of a IOL into the Human eye. This is indicated for the insertion only of models of intraocular lens that allow use of this injector in their approved labelling

Device Story

ASICO SofTip Injector System is a sterile, single-use manual device for delivering foldable intraocular lenses (IOLs) into the human eye. The system comprises a disposable injector, a cartridge, and a silicone-cushioned plunger head. Operation involves loading an IOL into the cartridge and applying direct forward manual pressure to the syringe-style plunger to push the lens through a tubular pathway and into the eye. Used in hospital or surgery center settings by physicians. The silicone cushion ensures smooth lens delivery without mechanical or optical damage. The device is intended for use with FDA-approved viscoelastic agents.

Clinical Evidence

Bench testing only. Testing included biocompatibility (Cytotoxicity ISO 10993-5, Systemic Toxicity ISO 10993-11, Intracutaneous irritation ISO 10993-10, Maximization Sensitization ISO 10993-10) and mechanical performance per ISO 11979-3:2006. All tests passed. A 5-year aging study on the cartridge and injector was also performed.

Technological Characteristics

Materials: Polycarbonate 144R (Blue for body, White for plunger/cap), Stainless Steel (SS304) spring, medical-grade lubricated polypropylene cartridge, medical-grade silicone tip. Principle: Manual syringe-type plunger. Dimensions: 5mm barrel tip. Sterilization: ETO (SAL 10^-6).

Indications for Use

Indicated for the insertion of foldable intraocular lenses (IOLs) into the human eye during surgical procedures, limited to IOL models that specify the use of this injector in their approved labeling.

Regulatory Classification

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.

Predicate Devices

MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE (K040837)
NAVIJECT SUB2-1P, MODEL: LP604430 (K092023)
LENSTEC LC INJECTION SYSTEM (K063802)

Related Devices

K133146 — BAUSCH + LUMB, VIS100 INJECTOR SYSTEM · Bausch & Lomb · Jan 3, 2014
K980696 — FOAM TIP INJECTOR · Staar Surgical Co. · Sep 11, 1998
K142056 — LIOLI IOL DELIVERY SYSTEM · Ast Products, Inc. · Apr 9, 2015
K091507 — RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 · Rayner Intraocular Lenses , Ltd. · Dec 4, 2009
K252540 — ACCUJECT Injector Set 2.1-1P (LP604590) · Medicel AG · Sep 16, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for ASICO. The logo is in black and white and features the company name in large, bold letters. There is a horizontal line underneath the company name. The registered trademark symbol is located in the upper right corner of the logo. #### SECTION 3 → 510(k) Summary The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR1807.92(a). ### 807.92(a)(1) # Submitter Information ASICO LLC 26 Plaza Drive Westmont, IL 60559 | Phone: | 630 986 8032 | |------------|--------------| | Facsimile: | 630 986 0065 | Contact Person: A.N.Gowtham June 17, 2011 Date: 807.92(a)(2) ASICO SofTip Injector System, AS-9300 Trade Name: Common Name: Injector Intraocular lens guide, Classification Name(s): CFR 886.4300 Classification Number: Regulatory class : Class I ( Reserve) 807.92(a)(3) ## Predicate Device(s) | | Device | |---------|---------------------------------------------| | K040837 | MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE | | K092023 | NAVIJECT SUB2-1P, MODEL: LP604430 | | K063802 | LENSTEC LC INJECTION SYSTEM | 807.92 (a)(4) {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the word "ASICO" in a bold, sans-serif font. The letters are black, and there is a horizontal line underneath the word. There is a registered trademark symbol to the right of the letter "O". There is a black rectangle in the middle of the letter "S". #### Device Description The ASICO SofTip Injector system is a sterile, single use device intended to insert a foldable intraocular lens through a surqical procedure in a Human eye. The system provides a tubular pathway through a incision, allowing the delivery of a IOL into the Human eye. This is indicated for the insertion only of models of intraccular lens that allow use of this injector in their approved labelling The plunger's head is covered by a silicone cushion that provide a good contact to the lens to ensure a smooth delivery. The plunger is advanced by direct forward motion applied to the syringe type plunger. The set consists of a disposable injector, a cartridge and a silicone tip. There are different Injector sets based on the type of cartridge that is used (AS-9300-16, AS-93001620, AS-9300-24,AS-9300-2420) The product is manufactured according to the ISO 13485:2003 Quality Standards and Quality System Requlations. The Injector body is manufactured from Polycarbonate 144R Blue. The plunger assembly which consists of plunger, shaft and outer and inner cap is made up of, Polycarbonate 144R white and the spring is made of stainless steel (SS304) under validated conditions. The cartridge is made from medical grade lubricated polypropylene and the silicon tip is also from medical grade. The injector system will be delivered sterile. #### 807.92(a)(5) #### Technological Characteristics The ASICO SofTip Injector system is a sterile, single use device intended to insert a foldable intraocular lens through a surgical procedure in a Human eye. The system provides a tubular pathway through a incision , allowing the delivery of a IOL into the Human eye. The plunger's head is covered by a silicone cushion that provide a good contact to the lens to ensure a smooth delivery. The plunger is advanced by direct forward motion applied to the syringe type plunger. This instrument has substantially equivalent technological characteristics to the predicate devices refer to the device matrix comparison chart below. The set consists of a disposable injector, a cartridge and a silicone tip. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "ASICO" in a bold, stylized font. The letters are large and black, with a thick, sans-serif typeface. A registered trademark symbol is present to the right of the letter "O". # Device Comparison Matrix | TRADE NAME | ASICO AS Injector system, AS-9300 | I MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE K040837 | NAVIJECT SUB2-1P MODEL: LP604430 K092023 | LENSTEC LC INJECTION SYSTEM K063802 | ADE NAME | ASICO AS Injector system, AS-9300 | MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE K040837 | NAVIJECT SUB2-1P, MODEL: LP604430/ K092023 | LENSTEC LC INJECTION SYSTEM K063802 | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | ASICO LLC | MEDICEL AG | MEDICEL AG | Lenstec LC | Materials | 1.Outer Body - Polycarbonate 144R BLUE 2.Plunger - Polycarbonate 144R WHITE 3.Cap - Polycarbonate 144R WHITE 4. spring is made of SS304 | Unable to Obtain | Unable to Obtain | 1.Outer Body - Polycarbonate 144R BLUE 2.Plunger - Polycarbonate 144R WHITE 3.Cap - Polycarbonate 144R WHITE 4. spring is made of SS304 | | Regulation number | 886.4300 | 886.4300 | 886.4300 | 886.4300 | Forward motion principle | Plunger/Syringe/scre w Type | Plunger/Syringe Type | Plunger/Syringe Type | Plunger/Syringe Type | | Product Code | MSS | MSS | MSS | MSS | Design | is a sterile, single use device | is a sterile, single use device | is a sterile, single use device | is a sterile, single use device | | Device Description | Intraocular Lens Guide | Intraocular Lens Guide | Intraocular Lens Guide | Intraocular Lens Guide | Sterilization | Single use device | Single use device | Single use device | Single use device | | 510(k) Number | Via this submission | K040837 | K092023 | K063802 | Where used | Hospital/ surgery centre | Hospital/ surgery centre | Hospital/ surgery centre | Hospital/ surgery centre | | Operating principle | The cartridge is loaded into the Injection System and the IOL is pushed through the cartridge into the eye | The cartridge is loaded into the Injection System and the IOL is pushed through the cartridge into the eye | The cartridge is loaded into the Injection System and the IOL is pushed through the cartridge into the eye | The cartridge is loaded into the Injection System and the IOL is pushed through the cartridge into the eye | compatible | Yes | Yes | Yes | Yes | | Patient Contact | Tip of the Injector to place the lens | Tip of the Injector to place the lens | Tip of the Injector to place the lens | Tip of the Injector to place the lens | Recommend to use with | FDA approved viscoelastic | FDA approved viscoelastic | FDA approved viscoelastic | FDA approved viscoelastic | | Intended Use | The ASICO SofTip Injector system is a sterile, single use device intended to insert a foldable intraocular lens through a surgical procedure in a Human eye. The system provides a tubular pathway through an incision, allowing the delivery of a IOL into the Human eye. This is indicated for the insertion only of models of intraocular lens that allow use of this injector in their approved labelling | The Medicel MultiJect injector for the intraocular lenses is indicated for the insertion of foldable intraocular lenses Ceeon913A and Tecnis Z9000 made by Pharmacia when used in conjunction with the Micro Glide cartridges | The Navijet Sub2-1P IOL injector and cartridge set for the intraocular lens is indicated for the insertion only of models of intraocular lens that allow use of this injector in their approved labelling | The Lenstec LC Injection system is intended for use in implantation of Staar Collamer Intraocular Lens model CC4204BF into the capsular bag following extracapsular extraction | Sterilization Method | ETO sterilization SAL Level 1X10-6 | ETO sterilization Unable to Obtain SAL level | ETO sterilization Unable to Obtain SAL level | ETO sterilization SAL Level 1X10-6 | | Diameter of Barrel Tip | 5mm | Unable to Obtain | Unable to Obtain | 5mm | | | | | | | Human Factors | By Doctors only | By Doctors only | By Doctors only | By Doctors only | | | | | | | Standards Met | ISO 11979-3: 2006 ISO 10993-5:2009 ISO 10993-10:2002 ISO 10993-10:2002 | Unable to Obtain | Unable to Obtain | ISO 11979-3: 2006 ISO 10993-5:2009 ISO 10993-10:2002 ISO 10993-10:2002 | | | | | | | Performance | Performance criteria met | Performance criteria met | Performance criteria met | Performance criteria met | | | | | | {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "ASICO" in a bold, black font. The letters are large and spaced closely together. There is a registered trademark symbol to the right of the letter "O". A horizontal line is present at the bottom of the word. Most of the predicate devices use the same principal (plunger/syringe type) to implant the lens into the eye and there for is very similar to each other. Difference can be the composition of the instrument. All the devices including ASICO AS-9000 injection system have been tested to according to Recognized Consensus Standards ISO 11979-3:2006. Ophthalmic implants --Intraocular lenses -- Part 3: Mechanical properties and test methods. (Ophthalmic): and they have passed the tests. There is nothing in the ASICO AS9000 injection system that negatively affects the safety or performance o {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "ASICO" in a bold, black font. The letters are large and spaced closely together. There is a registered trademark symbol to the right of the letter "O". A horizontal line is present in the middle of the word, obscuring part of the letters. #### Tests Performed The objective of the study was to demonstrate that the IOL's remain mechanically and optically undamaged after manipulation with the AS-9300 injection system. The instrument has passed all the necessary tests. We have performed various bio compatibility tests. As per FDA guidelines we have the following tests. Cytotoxicity Test, ISO Systematic Toxicity Test, Intracutaneous Test and Maximization Sensitization Test. Test results below. | Test | ISO Standard | Summary | Test Result | |------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Cytotoxicity Test | ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity | The Test article extract showed no evidence of causing cell lysis or toxicity. The test article extract met the requirements of the test since the grade was less than | Passed | | ISO Systematic Toxicity Test | ISO 10993-11:2006 Biological evaluation of medical devices Part 11: Tests for systemic toxicity | There was no mortality or evidence of systemic toxicity from the extracts. The test article extracts met the requirements of the study | Passed | | Intracutaneous Test | ISO 10993-10:2002 / And 1:2006 Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity | There was no Erythema and no edema from the SC test extract injected intracutaneously into the rabbits. There was very slight erythema and no edema from the SO test extract injected Intracutaneously into rabbits. Each test article met the requirements of the test since the difference between the test extract overall mean score and corresponding control overall mean score was 0.0 | Passed | | Maximization Sensitization Test | ISO 10993- 10:2002/Amd 1:2006 Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity | The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered sensitizers in the guinea pig maximization test. | Passed | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "ASICO" in a bold, sans-serif font. The letters are black, and the background is white. There is a registered trademark symbol to the right of the letter "O". The letter "S" has a horizontal line through it. We also have done a 5 year ageing study on the cartridge. The cartridges and silicone are being supplied to us by Lenstec which is one of our predicate companies. The plastic injector is supplied to Lenstec by us. We have included their report as it shows the IOL's remain mechanically and optically undamaged after manipulation. The Sterilization Validity study has been performed. . #### Substantial Equivalence Discussion The ASICO SofTip Injector system is a sterile, single use device intended to insert a foldable intraocular lens through a surgical procedure in a Human eye. The system provides a tubular pathway through a incision , allowing the delivery of a IOL into the Human eve. This is indicated for the insertion only of models of intraocular lens that allow use of this injector in their approved labelling The plunger's head is covered by a silicone cushion that provides a good contact to the lens to ensure a smooth delivery. The plunced by direct forward motion applied to the syringe type plunger. The set consists of a disposable injector, a cartridge and a silicone tip. This instrument has substantially equivalent technological characteristics to the predicate devices the Navijet and the multi-jet system from Medicel as well Lenstec LC Injection system. They use the same principal and have a similar silicon tip, injector and cartridge. ASICO cartridges are equivalent to Lenstec cartridges LC16, LC1620, LC24, LC2420. Lenstec supplies to ASICO the same cartridges and silicon tips they combine their cartridges with Injectors that ASICO supplies and sterilizes them similar to their LC injection system which is our predicate device and supplies to ASCIO under the ASICO SofTip Injector System, AS-9300 brand name. A brief device comparison is below. A detailed comparison matrix is listed below. | TRADE NAME | ASICO AS Injector system, AS-9300 | MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE K040837 | NAVIJECT SUB2-1P MODEL LP604430 K092023 | LENSTEC LC INJECTION SYSTEM K063802 | |-------------------------|--------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------|--------------------------------------------------------------| | Manufacturer | ASICO LLC | MEDICEL AG | MEDICEL AG | Lenstech LC | | Target Population | Different Lens companies | Different Lens companies | Different Lens companies | Use for their own lens | | Sterilization Method | ETO sterilization | ETO sterilization | ETO sterilization | ETO sterilization | | Device Description | Intraocular Lens Guide | Intraocular Lens Guide | Intraocular Lens Guide | Intraocular Lens Guide | | Operating principle | The cartridge is loaded into the | The cartridge is loaded into | The cartridge is loaded into the | The cartridge is loaded into the Injection System and the | ### Device Comparison Matrix {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "ASICO" in a bold, sans-serif font. The letters are large and black, and there is a registered trademark symbol to the right of the letter "O". There is a horizontal line below the word. | | Injection System and the IOL is pushed through the cartridge into the eye | the Injection System and the IOL is pushed through the cartridge into the eye | Injection System and the IOL is pushed through the cartridge into the eye | IOL is pushed through the cartridge into the eye | |-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Patient Contact | Tip of the Injector to place the lens | Tip of the Injector to place the lens | Tip of the Injector to place the lens | Tip of the Injector to place the lens | | Intended Use | The ASICO SofTip Injector system is a sterile, single use device intended to insert a foldable intraocular lens through a surgical procedure in a Human eye. The system provides a tubular pathway through a incision , allowing the delivery of a IOL into the Human eye. This is indicated for the insertion only of models of intraocular lens that allow use of this injector in their approved labelling | The Medicel MultiJect injector for the intraocular lenses is indicated for the insertion of foldable intraocular lenses Ceeon913A and Tecnis Z9000 made by Pharmacia when used in conjunction with the MicroGlide cartridges | The Navijet Sub2- 1P IOL injector and cartridge set for the intraocular lens is indicated for the insertion only of models of intraocular lens that allow use of this injector in their approved labelling | The Lenstec LC Injection system is intended for use in implantation of Staar Collamer Intraocular Lens model CC4204BF into the capsular bag following extracapsular extraction | Image /page/6/Picture/3 description: The image shows a table with different trade names and their corresponding models or systems. The trade names listed are ASICO AS, MULTIJECT, NAVIJECT, and LENSTEC LC INJECTION. The ASICO AS is an injector system AS-9300, MULTIJECT is an injector and microglide cartridge, NAVIJECT is SUB2-1P model LP604430 K092023, and LENSTEC LC INJECTION is a system K063802. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "ASICO" in a bold, sans-serif font. The letters are large and black, and there is a registered trademark symbol to the right of the letter "O". A horizontal line is present at the bottom of the image. #### 26 Plaza Drive, Westmont, IL 60559 U.S.A. Phone: 630-986-8032 • Fax: 630-986-0065 E--mail:info@asico.com • http://www.asico.com | K040837 | | | | | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | Forward motion principle | Plunger/Syringe Type | Plunger/Syringe Type | Plunger/Syringe Type | Plunger/Syringe Type | | Biocompatible | Yes | Yes | Yes | Yes | | Design | is a sterile, single use device | is a sterile, single use device | is a sterile, single use device | is a sterile, single use device | | Sterilization | Single use device | Single use device | Single use device | Single use device | | Where used | Hospital/ surgery centre | Hospital/ surgery centre | Hospital/ surgery centre | Hospital/ surgery centre | | Materials | 1.Outer Body Polycarbonate 144R BLUE 2.Plunger Polycarbonate 144R WHITE 3.Cap Polycarbonate 144R WHITE 4. spring is made of SS304 | Unable to Obtain | Unable to Obtain | 1.Outer Body Polycarbonate 144R BLUE 2. Plunger Polycarbonate 144R WHITE 3.Cap Polycarbonate 144R WHITE 4. spring is made of SS304 | #### Summary The test have been done according to Recognized Consensus Standards ISO 11979-3:2006, Ophthalmic implants - Intraocular lenses -- Part 3: Mechanical properties and test methods. (Ophthalmic): The cartridges are being supplied to us by Lenstec which is one of our predicate companies. We have included their report as it shows the IOL's remain mechanically and optically undamaged after manipulation. We also have included a 5 year ageing study on the cartridge and injector. The Sterilization Validity study and summary are also included for review We have performed various bio compatibility tests. As per FDA guidelines we have done the following tests. Cytotoxicity Test, ISO Systematic Toxicity Test, Intracutaneous Test and Maximization Sensitization Test We thereby conclude that ASICO AS-9300 SofTip Injecotion system is has substantially equivalent technological characteristics to the predicate devices the Navijet and the multi-jet system from Medicel as well Lenstec LC Injection system {8}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine and healing. The caduceus is depicted as a bird-like figure with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 ASICO LLC c/o Mr. Casey Conry Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. Melville, NY 11747 JUN 2 9 2011 Re: K103495 Trade/Device Name: ASICO SofTip Injector System, AS-9300 Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I (reserve) Product Code: MSS Dated: June 17, 2011 Received: June 21, 2011 Dear Mr. Conry: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. {9}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Image /page/9/Picture/5 description: The image shows a signature in black ink on a white background. The signature appears to be stylized and cursive, with a loop extending downwards and to the left, forming the main body of the signature. There is a smaller loop or curve at the top right, possibly representing the end of the name or initials. The signature is simple and elegant, with clean lines and a flowing design. Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ # Indications for Use 510(k) Number (if known): K103495 Device Name: __ ASICO SofTip Injection System Indications for Use: The ASICO SofTip Injector system is a sterile, single use device intended to insert a foldable intraocular lens through a surqical procedure in a Human eye. The system provides a tubular pathway through a incision , allowing the delivery of a IOL into the Human eye. This is indicated for the insertion only of models of intraocular lens that allow use of this injector in their approved labelling 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) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Page 1 of 1 510(k) Number K103495