(183 days)
Not Found
Not Found
No
The device is a chemical cleaner for contact lenses and the summary focuses on its chemical, physical, and microbiological properties, not data processing or analysis.
No.
The device is a cleaner for contact lenses, not a product intended for therapeutic use on the human body.
No
The device is a daily cleaner for contact lenses, designed to remove debris. It does not analyze or interpret biological data to diagnose a disease or condition.
No
The device is a contact lens cleaning solution, which is a chemical product, not software. The description details its chemical composition, packaging, and performance studies related to its cleaning effectiveness and stability, none of which are characteristic of a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to clean contact lenses, which are medical devices worn on the eye. It is not intended to diagnose, monitor, or treat any medical condition by examining specimens derived from the human body.
- Device Description: The description details a cleaning solution for contact lenses, not a product designed to analyze biological samples.
- Anatomical Site: The device is applied to contact lenses, not directly to an anatomical site for diagnostic purposes.
- Performance Studies: The performance studies focus on the cleaning effectiveness, stability, sterility, and compatibility of the solution with contact lenses. They do not involve the analysis of biological specimens or the evaluation of diagnostic accuracy metrics like sensitivity, specificity, or AUC.
- Key Metrics: The key metrics reported are related to the chemical and physical properties of the cleaner and its effectiveness in cleaning and preserving contact lenses, not diagnostic performance.
IVD devices are specifically designed to perform tests on specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or treatment. This device does not fit that description.
N/A
Intended Use / Indications for Use
Sereine Extra Strength Daily Cleaner is a daily cleaner for use on contact lenses to remove proteins, lipids and other accumulated debris which collects on contact lenses during wear.
Sereine Extra Strength Daily Cleaner is intended for use with all soft (hydrophilic) lenses and hard (PMMA) lenses on a daily basis. The cleaner is for use on lenses immediately following removal from the eye and prior to disinfection.
Sereine Extra Strength Daily Cleaner is intended for use each time the lenses are removed from the eye.
Sereine Extra Strength Daily Cleaner is not intended for use in the eye. All cleaner residue must be rinsed from the lenses after cleaning with either the Opti-One Solution (for hydrophilic lenses) or water (for hydrophobic lenses).
Sereine Extra Strength Daily Cleaner is indicated for use as a daily cleaner for removal of film, deposits and other debris which accumulate on soft (hydrophilic) and hard (PMMA) contact lenses.
Sereine Extra Strength Daily Cleaner may be used with either thermal (heat) or chemical (cold) disinfection systems. Follow the recommendation of your eye care practitioner when disinfecting your lenses.
Product codes
LPN; HPX
Device Description
Sereine Extra Strength Daily Cleaner is a sterile, viscous, aqueous solution with an alkaline pH. The cleaner contains an amphoteric surfactant to aid in the removal of proteins, lipids and other debris which accumulate on contact lenses during wear. The cleaner is not meant for use in the eye and must be rinsed from the lenses.
Sereine Extra Strength Daily Cleaner is packaged in a 1 FL OZ plastic bottle (polyethylene) with red dropper tip (polyolefin) and an over-cap (polypropylene). It has an outside cardboard carton. It has an expiration date coded on the bottle, which is two years from the date of bottling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-clinical tests:
A. Stability Study:
- The stability or shelf-life study for Sereine Extra Strength Daily Cleaner was conducted using three lots stored at ambient temperature (between 60 and 80°F) for two years.
- Characteristics monitored: pH, Viscosity, Active Ingredients (UV-visible spectra), Physical Appearance (bottle, tip, cap, product for precipitates, turbidity, color change), and Sterility.
- Results: The pH and viscosity remained within acceptance standards. Active ingredients were stable as indicated by UV-visible spectra. Physical appearance showed no issues. All three stored lots tested were sterile.
- Preservative effectiveness with 14-day re-challenge tests were performed on three stored lots according to FDA Guidelines, and the lots passed.
- Conclusion: Shelf-life studies indicated that the Sereine Extra Strength Daily Cleaner is safe and effective for the proposed shelf-life of two years.
B. Chemistry:
- Solution Compatibility:
- Tested with soft (hydrophilic) lenses (ten Metrotint and ten Horizon 55 lenses) and hard (PMMA) lenses (ten blue PMMA lenses).
- Hydrophilic lenses: Cleaned daily for 30 cycles, disinfected with Opti-One Solution. Optical parameters and physical appearance recorded before and after.
- PMMA lenses: Cleaned daily for 30 cycles, disinfected with Sereine wetting or soaking solution. Optical parameters and physical appearance recorded before and after.
- Results: No significant changes in optical parameters or physical appearance were noted for either lens type.
- Cleaning Effectiveness:
- Determination of the critical micelle concentration of the surfactant and the surface tension of the solution was done according to the "Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products".
C. Microbiological Tests:
- Sterility:
- Sterility of Sereine Extra Strength Daily Cleaner was confirmed using USP methodology by Nelson Laboratories, Inc.
- All lots tested were sterile.
- Conclusion: The manufacturing process ensures the solution is sterile.
- Preservative Effectiveness with 14-day re-challenge:
- Conducted by Northview Pacific Laboratories according to "Pre-market Notification (510(k)) Guidance Document for Contact Lens Care Products".
- Sereine Extra Strength Daily Cleaner passed the test and is safe for use in a multi-dose container.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MiraFlow Extra Strength Daily Cleaner
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.5928 Soft (hydrophilic) contact lens care products.
(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
0
K011561 NOV 20 2001
Optikem International, Incorporated 2172 South Jason Street Denver, Colorado 80223 USA
510(K) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS
- Submitter's Name
Optikem International, Inc. 2172 South Jason Street Denver, CO 80223
Telephone: 303-936-1137 FAX: 303-936-7320
- Contact Person
Sally Cook President
- Date Summary was Prepared:
May 8, 2001
Sereine
Contact Lens
Solutions
Optisoap
Hand Soap
1
4. Name of Device
Trade Name: Sereine Extra Strength Daily Cleaner Common Name: Daily Cleaner for Contact Lenses -Classification Name: Contact Lens Cleaner
-
- Legally Marketed Device to Which Equivalence is Claimed:
MiraFlow Extra Strength Daily Cleaner, CIBA Vision
Cleaner, Carength Ca., 00155 Corporation, Duluth, GA 30155.
- Legally Marketed Device to Which Equivalence is Claimed:
Description of Device: 6.
Sereine Extra Strength Daily Cleaner is a sterile, viscous, aqueous Sereine Extra Strength Dany Cloaner contains no added solution with an alkaline pri. The citains an amphoteric surfactant to aid in
preservatives. The cleaner contains an amphoteric surfactant to aid in preservatives. The cleaner contains and other debris which accumulate on the removal of proteins, lipids and other dealer is not meant for use in the eye
contact lenses during wear. The cleaner is not meant for use in the eye contact lenses during weak ed from the lenses.
Sereine Extra Strength Daily Cleaner is packaged in a 1 FL OZ plastic Sereine Extra Strength Daily Citcano is passessorse on white bottle (polyethylene) with red uropper tip (poryon) (and carton. It has an
over-cap (polypropylene). It has an outside cardboard carton. It has an
the exp (polypropylene) over-cap (polypropylene). It som the date of bottling.
2
Intended Use of the Device: 7.
Sereine Extra Strength Daily Cleaner is a daily cleaner for use Sereine Extra Daving in ids and other accumulated debris which collects on contact lenses during wear.
Sereine Extra Strength Daily Cleaner is intended for use with all soft (hydrophilic) lenses and hard (PMMA) lenses on a an soft (1) arope cleaner is for use on lenses immediately following removal from the eye and prior to disinfection.
Sereine Extra Strength Daily Cleaner is intended for use each time the lenses are removed from the eye.
Sereine Extra Strength Daily Cleaner is not intended for use in Screme Entra Buche insed from the lens after cleaning with either the Cyc and mast cophilic lenses) or water (hydrophobic lenses).
3
-
- Technological Characteristics of the Device as Compared to the Predicate Device:
| MiraFlow | Sereine | |
|---|---|---|
| pH | 8.3 | 8.3 |
| Viscosity | 74 cp | 74 cp |
| Total solids | 20.6% | 20.8% |
| Sterility | Sterile | Sterile |
| UV-visible spectrum | Match Miraflow |
4
DESCRIPTION OF TESTS CONTAINED IN TABLE ON PREVIOUS PAGE:
1. pH
The pH of three different lots of MiraFlow Extra Strength Daily File pri of there different lots of Sereine Extra Strength Daily Cleaner was obtained by using a calibrated Piccolo pH meter. The results of the three lots were averaged.
2. Viscosity
The viscosity of the MiraFlow Extra Strength Daily Cleaner and the Sereine Extra Strength Daily Cleaner was determined using a Gilmont Falling Ball Viscometer. Three lots of each cleaner were tested and the results averaged. The Gilmont Falling Ball Viscometer was Size 2 (2-100 cps) with a stainless steel I alling Dur . The viscometer was placed in a constant temperature water bath of 25C. Approximately 5 ml of solution was placed in the viscometer and the stainless steel ball was dropped. The time for the stainless steel ball to descend through the liquid was timed with a calibrated Cole-Parmer Model #94410-20 Stop Watch. The viscosity was calculated by averaging the times for the lots of MiraFlow Extra Strength Daily Cleaner. The procedure was repeated for the lots of Sereine Extra Strength Daily Cleaner.
5
DESCRIPTION OF TESTS CONTAINED IN TABLE (CONT.)
3. Total Solids
The total non-volatile solids were determined by weighing an The total non-voluene vished product of MiraFlow Extra Strength Daily Cleaner in a porcelain evaporating dish. Streign Dany Cloater in been previously weighed (empty). The evaporating dish had boing oven at 105C. The dish was The dish was placed in a diffing obtained. The procedure was Three uned using Sereine Extra Strength Daily Cleaner. Three samples of each product were tested and the results averaged. Sumples or courts were comparable as to total non-volatile solids.
4. Sterility
MiraFlow Extra Strength Daily Cleaner is labeled as a sterile product. Sereine Extra Strength Daily Cleaner was tested for sterility by Nelson Laboratories, Inc., Salt Lake City, UT storing of Norther contained in USP 24. Sereine Extra Strength Daily Cleaner was tested for sterility by randomly sampling Daily Cleaner wers from the lot. Sereine Extra Strength Daily Cleaner was found to be sterile.
6
DESCRIPTION OF TESTS CONTAINED IN TABLE (CONT).
5. UV-Visible Spectra Comparison
MiraFlow Extra Strength Daily Cleaner and Sereine Extra Strength Milal 10W Examer were compared using a Shimadzu UV-visible Dany Cloudiol were Sompl UV-160. The cleaner was placed neat in a 10 mm rectangular silica absorption cell. The reference was ill a 10 min receanganas orbance range was 0-2.5 absorbance units and the spectral range was 200-1000 nm. The spectra of the two cleaners were comparable indicating like components.
7
9. Summary of Non-clinical tests
The following non-clinical tests were performed on Sereine The following non emileaner. These tests were not performed Latra Strength Daily Cleaner as Optikem On Mind Tow Encra Ses not have access to materials and data necessary to conduct these tests.
Although the non-clinical tests were not performed on MiraFlow Anthough the non cinner for comparison, it is presumed that Extra Strengan Daily Cleaccessfully in order to obtain pre-market approval.
A. Stability Study
The stability or shelf-life study for Sereine Extra Strength Daily Cleaner was conducted using lots stored at ambient temperature for two years. The ambient temperature was between 60 and 80 F and was recorded on a daily basis as part of the quality assurance program. Three lots of Sereine Extra Strength Daily Cleaner were tested for stability. These lots were bottled in 1 FL OZ (30 ml) plastic bottles. Bottles were capped and the caps sealed with tamper-resistant seals. Bottles were not subjected to any specific conditions as far as humidity or light. The relative humidity is recorded on a daily basis as part of the quality assurance program.
8
SUMMARY OF SAFETY AND EFFECTIVENESS
Summary of Non-clinical tests (cont). 9.
A. Stability Study (cont).
The following characteristics of Sereine Extra Strength Daily Cleaner were monitored:
- pH
The pH of each of three lots was taken using a calibrated The pH of each of thee lots was compared to the original
Piccolo pH meter. The result was compared to the original Piccolo pH meter. The finished device acceptance pH obtained as part of the humaneng date. The pH was not
standards from the original bottling and storage standards from the original soming and storage.
- Viscosity
The viscosity of each of three lots was measured using a The viscosity of each of the City of Ciscometer. The viscosity Gilmont Size 2 Falling Ball Type Tibecausessity as determined at the time of bottling.
- Active Ingredients
The ingredients were determined using a Shimadzu UV-visible The ingredients were determinou uses acception silica absorption Spectrophotometer, Model 100 will a scan of 200-800 mm.
cells. Three stored lots were measured in a scan of 200-800 mm. cells. Three stored lots were was not performed on the lots as part of the original finished device acceptance, the scans were as part of the original imislied on the use. The ingredients were
compared to a recently formulated batch. The ingredied as indicated compared to a recently formations of the storage period as indicated by the UV-visible spectra.
9
K 0 11 56 1
510(k) SUMMARY
SUMMARY OF SAFETY AND EFFECTIVENESS
Summary of Non-clinical tests (cont.) g.
A. Stability Study (cont.)
-
- Physical Appearance
Physical appearance of the bottle, tip and cap was observed. Physical appearance of the occases, inc. are discoloration, cracks, Packaging components were Extra Strength Daily Cleaner itself was observed for any precipitates, turbidity or color change. was observed for any precipitates, turelows of the chemical components were noted.
- Physical Appearance
-
- Sterility
The sterility of the stored solution was tested using USP The Stermly of the Stored Stated States, Inc., Salt Lake City, UT. All three stored lots tested were sterile.
- Sterility
- Preservative Effectiveness with 14 day re-challenge
Preservative effectiveness testing of three stored lots was performed by Northview Pacific Laboratories, Inc. of Hercules, CA. The testing was conducted according to the FDA Guidelines CA. The testing was conceeded ation (510(k)) Guidance Document . For Contact Lens Care Products". The stored lots passed the requirements for this test.
Conclusion:
Shelf-life studies indicated that the Sereine Extra Strength Daily Cleaner is safe and effective for the period of the proposed shelf-life of two years.
10
9. Summary of Non-clinical tests (cont.)
B. Chemistry
1. Solution Compatibility
The compatibility of Sereine Extra Strength Daily Cleaner with soft (hydrophilic) lenses and hard (PMMA) lenses with soft (figuropining) tofnen ing the "Solution Compatibility was unlined in the "Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products". Ten lenses of Metrotint (enhancing tints of polymacon, 38% water) and ten lenses of Horizon 55 (visibility tints of 55% water) were used to test solution compatibility of hydrophilic lenses. Metrotint lenses are manufactured by Metro Optics, Austin, TX. Horizon 55 lenses are by Medio Opace, Westcon Contact Lenses, Grand Junction, CO. Ten PMMA lenses were also tested for compatibility with Sereine Extra Strength Daily Cleaner. These were blue lenses manufactured by Lens Dynamics, Lakewood, CO. The lens blanks were manufactured by Optikem Polymers of Englewood, CO.
The optical parameters were recorded before the test. Lenses were inspected for any physical defects. For hydrophilic lenses, each lens was flexed and then cleaned with Sereine Extra Strength Daily Cleaner as per product directions. After rinsing with sterile saline, the lenses were placed in a lens case and disinfected with Opti-One Solution (Alcon Laboratories, Ft Worth, TX) as per label instructions. After disinfection the lenses were removed from the lens case and the cycle repeated. The procedure was repeated for 30 cycles for each lens. After the 30 proces, the lens parameters and physical appearance of the lenses were again recorded.
11
Summary of Non-clinical tests (cont.) ல்
B. Chemistry (cont.)
1. Solution Compatibility
For PMMA lenses, the lenses were cleaned with Sereine Extra For PMMA lenses, the lenses were cicance in The lenses were
Strength Daily Cleaner as per label directions. The lenses were Strength Daily Cleaner as per iaber as per interes were
rinsed with water and placed in lens cases. The lenses were rinsed with water and placed in left soaking Solution as per disinfected with Sereine wetting or boulenges were removed
label directions. After disinfection, the lenses were removed label directions. And the cycle repeated. After 30 cycles,
from the lens cases and the cycle repeated. After 30 cycles, from the lens cases and the Cycle reposee of the lenses were the parameters and physical appearantee on
No significant changes in optical parameters or physical No significant changes no opine Extra Strength Daily appearance was noted. Serence DAGE Burenge
- Cleaning Effectiveness
The Determination of the critical micelle concentration of the The Determination of the circles tension of the solution done according
surfactant and the surface tension of the solution (510(k)) surfactant and the surface tension of also to the bottfication (510(k))
to the procedure contained in "Premarket North Corp. Products" to the procedure contained in "re Lens Care Products", Guidance Document for Someon Donator Donator Book Testing Appendix B. Testing Company, Inc. of Passaic, NJ.
12
9. SUMMARY OF NON-CLINICAL TESTS (CONT.)
C. Microbiological Tests
- Sterility
Sterility of Sereine Extra Strength Daily Cleaner was confirmed using USP methodology. Sterility testing of the product was done by Nelson Laboratories, Salt Lake City, UT. All lots tested were sterile. The manufacturing process used by Optikem International, Inc. to produce Sereine Extra Strength Daily Cleaner was adequate to ensure that the solution was sterile.
- Preservative Effectiveness with 14 day rechallenge
Preservative effectiveness testing was conducted according to the procedure outlined in "Pre-market Notification (510(k)) Guidance Document for Contact Lens Care products". The testing was conducted by Northview Pacific Laboratories, Hercules, CA.
Sereine Extra Strength Daily Cleaner passed the test for preservative effectiveness and is safe for use in a multi-dose container.
13
10. Conclusions
Based on the data outlined on the preceding pages, Sereine Extra
tion of the outlined offered officative for use as a daily clear Based on the data outlined on the preceding pagos, our as a daily cleaner for
Strength Daily Cleaner is safe and effective for use as a daily cleaner for Strength Daily Cleaner is safe un deposits and debris from the removal of accumulated (PMMA) lenses. The expiration date of
soft (hydrophilic) and bard (PMMA) lensessmiste based on data outlined soft (hydrophilic) and hard (PMMA) tenses. "The expropriate based on data outlined on the preceding pages.
14
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/14/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV Z 0 2001
Ms. Sally Cook President, Optikem International, Inc. Wilsa, Incorporated 2172 South Jason Street Denver, CO 80223
Re: K011561
K011501
Trade/Device Name: Sereine Extra Strength Daily Cleaner Regulation Number: 21 CFR 886.5928 Regulation Number: 21 Of St Irophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN; HPX Dated: October 1, 2001 Received: October 2, 2001
Dear Ms. Cook:
We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 310(ts) notheration of the indications for the indications for above and we have determined the cence is substainly of commence prior to May 28, 1976, 1976, 1976, 1976, 1976, 1976, 1976, use stated in the enclosure) to device interestments, or to devices that have been the enactment date of the Medical Device runes of Food, Drug, and Cosmetic Act
reclassified in accordance with the provisions of the Federal controls provisions of reclassified in accordance with the provisions on the general controls provisions of the (Act). You may, therefore, market the actives seauirements for annual registration,
Act. The general controls provisions of the Act include requirements mishranding Act. The general controls provisious of the Act include requiremisms against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III
n major If your device is classified (see above) into essues additional controls. Existing major (Premarket Approval), it may be subject to such and in the Code of Federal Regulations, Title 21,
regulations affecting your device can be found in the Code of Federal parth regulations affecting your device can or in the management on assumes compliance with the Parts 800 to 895. A substantially cquivalents, as set forth in the Quality System
Current Good Manufacturing Practice requirements, as set forth in the Rest, 800 and that, Current Good Manufacturing Fractic requiremently is over CFR Part 820) and that, through
Regulation (QS) for Medical Devices: General regulation (21 CFR Parily such Regulation (QS) for Medical Devices. Ocher a voginistration (FDA) will verify such periodic QS inspections, the Food and Drag regulation may result in regulatory action. In the Federal assumptions. Tandre to comply with the Other toge oncerning your device in the Federal addition, FDA may publish lurther announcements on notification submission does not affect
Register. Please note: this response to your premarket not for devices under Register. Flease note: this response to your f 542 of the Act for devices under any obligation you might have under sociologio sportions, or other Federal laws or regulations. I
15
Page 2 - Ms. Sally Cook
This letter will allow you to begin marketing your device as described in your Section 510(k)
. The subscription for a Tim FDA freding of sybstantial equivalence of your dev This letter will allow you to begin marketing your device of your device to a would and the research I its retect will and of the FDA finding of substantial equivalence of your device to trigure of the first of the first of the for proceed to the market.
procedure specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your device on our labeling regulation on earther Office of
additionally 21 CFR Part 809.10 for in vited diagnosic devices, please contact t If you attended in the most of on the diagnostic devices); pressoons on the promotion and advertising of
Compliance at (301) 594-4613. Additionally, for questions on the pro Compliance at (301) 594-4613. Additionally, for questions on and the promotes and Ocuped on the Office of Compliation of Compliance an (101). "C/C/R Part 807.97).
your device, please contact the Office of Compliation "(21CFR Part 807.97).
regulation entitl regulation entitled, "Misbranding by responsibilities may be obtained from the Division
Other general information on your responsibilities under the Act may be obtained from rogeneral information on your responsibilities under the Act may 10 of the many of the manager (800)
of Small Manufacturers, International and Consumer Assistance at its tol of Small Manufacturers, International its Internet address .
638-2041 or (301) 443-6597 or at its Internain html 638-2041 of (501) 175-604) 175-607 14-15-2041 11-1
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
16
NOV 2 0 2001
INDICATIONS FOR USE STATEMENT
Sereine Extra Strength Daily Cleaner is indicated for use as a daily
our and other that the first be acits and other debris which accums Sereine Extra Strength Daily Cleaner is Indicator for which accumulate
cleaner for removal of film, deposits and other debris which accumulate
s and of the county in and DJ A cleaner for removal of film, deposits and other were are and
Sereine Extra Strength Dailly Cleaner may be used with either thermal
s and the success to belief of ation systems . Follow the recommends Sereine Extra Strength Dailly Cleaner may be used with exammendation
(heat) or chemical (cold) disinfection systems. Follow the recommendation
Services of chemical (cold) di (heat) or chemical (cold) disinicollor systems
of your eye care practitioner when disinfecting your lenses.
Eis O Ph.D.
(Division Sign-Off) Division of Ophthalmic Devices Koll561 510(k) Number_
Over-the-Counter Use