(84 days)
Not Found
Not Found
No
The 510(k) summary describes a process for tinting existing soft contact lenses using chemical reactions with color additives. There is no mention of any computational or algorithmic processes, let alone AI or ML. The device description focuses solely on the physical and chemical aspects of the tinting process and the resulting lens characteristics.
No.
The device's intended use is to enhance or alter the apparent eye color, which is a cosmetic purpose, not a therapeutic one. The description explicitly states it does not affect iris color and its optical parameters remain the same as originally prescribed.
No
The device is a cosmetic contact lens intended for enhancing or altering eye color, not for diagnosing any medical conditions.
No
The device description clearly states it is a "Color Enhanced Tinted Soft Contact Lens" and describes a physical manufacturing process involving tinting and color additives applied to a contact lens. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The COLORSOFT. Color Enhanced Tinted Soft Contact Lens is a medical device intended to be worn on the eye to enhance or alter the apparent eye color. It is a physical device that interacts with the body externally, not a test performed on a biological sample.
- Intended Use: The intended use is purely cosmetic (enhancing/altering eye color) and for ease of handling (visibility tint). It does not involve diagnosing, monitoring, or screening for any disease or condition.
- Device Description: The description details the physical characteristics of the lens, the tinting process, and the materials used. It does not describe any analytical or diagnostic function.
Therefore, the COLORSOFT. Color Enhanced Tinted Soft Contact Lens falls under the category of a medical device, specifically a contact lens, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The COLORSOFT, Color Enhanced Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color. The COLORSOFT visibility-handling tint provides for ease of patient handling and does not effect iris color.
Except for decreased light transmittance due to the tint intensity, the pre-tinted lens optical parameters remain the same as originally prescribed for the user prior to tinting. The lens is to be disinfected according to the original lens manufacturer's recommendation.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
COLORSOFT. Color Enhanced Tinted Soft Contact Lens are color enhanced soft contact lenses that have been previously prescribed for a specific patient. They have been supplied to Colorsoft Laboratories to be modified by a tinting process using color additives that have been listed as safe for contact lenses in accordance with the FDA's color additive regulations. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed color reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The COLORSOFT. Color Enhanced Tinted Soft Contact Lens are available in a light, medium or dark shade of the following enhance colors; Colorsoft Blue, Deep Blue, Aspen Green, Aquamarine, Yellow, Violet, Red, Chocolate, and Amber. COLORSOFT, Color Enhanced Tinted Soft Contact Lens are also available in a standard blue visibility-handling tint.
The color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used either alone or in combination are: reactive blue 21, reactive blue 21, reactive blue 19, reactive blue 4, reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens.
The following are tint patterns available to the practitioner:
- Clear Pupil diameter (2,00mm to 8,00mm), standard is 4,5mm.
- Annular (iris) diameter (8.00mm to 13.5mm), standard is 11.5mm diameter.
- Black pupil diameter (2.0mm to 12.5mm), standard is 4.0mm diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.
0
JUN 3 ............................................................................................................................................................................
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | K990815 |
|---|---|
| -------------------------------- | --------- |
Applicant information:
| Date Prepared: | March 12, 1999 |
|---|---|
| Name: | Colorsoft Laboratories Corporation |
| Address | 623 Glacier Drive |
| Grand Junction, CO 81503 | |
| Contact Person: | Ms. Deanna Werber |
| President | |
| Phone Number: | (970) 248-9445 |
| USA Consultant: | Martin Dalsing, |
| Med-Vice Consulting, Inc. | |
| Consultant for Colorsoft Laboratories Corporation | |
| 623 Glacier Drive | |
| Grand Junction, CO 81503 | |
| (970) 243-5490 | |
| Fax #: (970) 243-5501 | |
| E-mail: mdalsing@gj.net |
Device Information:
| Device Classification: | Class II |
|---|---|
| Classification Number: | LPL |
| Trade Name: | COLORSOFT, Color Enhanced Tinted Soft Contact |
lens for Daily Wear
Lenses, Soft Contact, Daily Wear Classification Name:
1
Substantially Equivalent Devices:
The "COLORSOFT" tinted soft contact lens is substantially equivalent to the DURASOFT 2 COLORS tinted soft contact lens, the predicate device.
INDICATIONS FOR USE:
The COLORSOFT. Color Enhanced Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eve color. The COLORSOFT visitint provides for ease of patient handling and does not effect iris color.
Except for decreased light transmittance due to the tint intensity, the pre-tinted lens optical parameters remain the same as originally prescribed for the user prior to tinting. The lens is to be disinfected according to the original lens manufacturer's recommendation.
Device Descriptive Characteristics:
COLORSOFT. Color Enhanced Tinted Soft Contact Lens are color enhanced soft contact lenses that have been previously prescribed for a specific patient. They have been supplied to Colorsoft Laboratories to be modified by a tinting process using color additives that have been listed as safe for contact lenses in accordance with the FDA's color additive regulations. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed color reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The COLORSOFT. Color Enhanced Tinted Soft Contact Lens are available in a light, medium or dark shade of the following enhance colors; Colorsoft Blue, Deep Blue, Aspen Green, Aquamarine, Yellow, Violet, Red, Chocolate, and Amber. COLORSOFT, Color Enhanced Tinted Soft Contact Lens are also available in a standard blue visibility-handling tint.
The color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used either alone or in combination are: reactive blue 21, reactive blue 21, reactive blue 19, reactive blue 4, reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens.
The following are tint patterns available to the practitioner:
- Clear Pupil diameter (2,00mm to 8,00mm), standard is 4,5mm. ।
- Annular (iris) diameter (8.00mm to 13.5mm), standard is 11.5mm diameter. -
- -Black pupil diameter (2.0mm to 12.5mm), standard is 4.0mm diameter.
2
The following table summarizes Colorsoft Laboratories claim of substantial equivalency in terms of safety and efficacy to the predicate devices previously mentioned
| 1.) | INTENDED USE | Daily wear, Soft (hydrophilic) contact
lens | Daily wear, Soft (hydrophilic) contact
lens |
|-----|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2.) | INDICATION | The Colorsoft Choices Soft Contact
Lenses for daily wear are indicated for
enhancing and/or altering the apparent
eye color. The Colorsoft Choices visitint
provides for ease of patient handling and
does not effect iris color. The lens is to
be disinfected following the original
manufacturer's instructions. | The Durasoft 2 Colors for daily wear are
indicated for enhancing and/or altering
the apparent eye color, including ocular
masking. |
| 3.) | ACTIONS | In its hydrated state, when placed on the
cornea, the lenses act as a refracting
medium to focus light rays on the retina. | In its hydrated state, when placed on the
cornea, the lenses act as a refracting
medium to focus light rays on the retina. |
| 4.) | FDA "listed"
colored additives | The reactive colored additives consist of
reactive black 5, reactive blue 4, reactive
blue 19, reactive 21, reactive blue 163,
reactive yellow 15, reactive yellow 86,
reactive orange 78, reactive red 11 and
reactive red 180. | The colored pigments consist of iron
oxides, chromium oxide greens, titanium
dioxide, [phthalo-cyaninato (2-)] copper
carbazole violet and phthalocyanine
green. |
| a. | Uses
and
restrictions | The color additives listed above may be
used to color contact lenses in amounts
not to exceed the minimum reasonably
required to accompish the intended
coloring effect. | The color additives listed above may be
used to color contact lenses in amounts
not to exceed the minimum reasonably
required to accompish the intended
coloring effect. |
| 5.) | Color Additive
Characteristics | The color additives used are not removed
by lens handling and
cleaning/disinfecting procedures. The
optical and performance characteristics
are not altered by the lens coloring
process. | The color additives used are not removed
by lens handling and
cleaning/disinfecting procedures. The
optical and performance characteristics
are not altered by the lens coloring
process. |
| 6.) | Colors Offered | Colorsoft Blue, Deep blue, Aspen Green,
Jade, Aquamarine, Yellow, Violet, Red,
Chocolate, and Amber | Sky blue, Jade green, Aquamarine and
Violet blue |
Table #1 - Substantial Equivalence
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 1939
Mr. Martin Dalsing Med-Vice Consulting, Inc. Consultant for Adventure in Colors, Inc. 623 Glacier Drive Grand Junction, CO 81503
Re: K990815 Trade Name: COLORSOFT, Color Enhanced Tinted Soft Contact lens for Daily Wear Regulatory Class: II Product Code: 86 LPL Dated: March 12, 1999 Received: March 11, 1999
Dear Mr. Dalsing:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
4
Page 2 - Mr. Martin Dalsing
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
Device Name:
COLORSOFT, Color Enhanced Tinted Soft Contact lens for Daily Wear
INDICATIONS FOR USE:
The COLORSOFT, Color Enhanced Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color. The COLORSOFT visibility-handling tint provides for ease of patient handling and does not effect iris color.
Except for decreased light transmittance due to the tint intensity, the pre-tinted lens optical parameters remain the same as originally prescribed for the user prior to tinting. The lens is to be disinfected according to the original lens manufacturer's recommendation.
(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel W.C. Brown, Ph.D.
X Prescription Use (Per 21 CFR 801 109)
Division Sion-Off Division of Ophthalmic Devices
J
Over-The-Counter Use
510(k) Number K990815
(Optional format 1-2-96)