(110 days)
No
The 510(k) summary describes lathe-cut rigid gas permeable contact lenses and their materials, intended for correcting refractive error and managing irregular corneal conditions. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies described are bench testing and bioburden testing, not related to AI/ML performance.
Yes
The device is indicated for the "management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery," which points to a therapeutic use beyond simple vision correction.
No
Explanation: The device, BostonSight IC Corneal & Scleral Lenses, is indicated for correction of refractive error and management of irregular corneal conditions. It is a therapy device (a contact lens) and not a device that diagnoses a condition.
No
The device description clearly states that the device is a physical, lathe-cut rigid gas permeable (RGP) contact lens made from specific materials. It also mentions packaging and shipping in contact lens cases and solutions, all of which are physical components. There is no mention of any software component being the primary or sole function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of refractive error and management of irregular corneal conditions. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The device is a contact lens, which is a medical device used to correct vision. It does not perform any tests on biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Activity: There is no mention of the device being used to detect, measure, or analyze any biological markers or substances for diagnostic purposes.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (on the body) for vision correction and management.
N/A
Intended Use / Indications for Use
The BostonSight IC Corneal & Scleral Lenses for Daily Wear are indicated for the correction of refractive error in aphakic and not aphakic persons. The lenses may be prescribed in otherwise non-diseased eves that require a rigid gas permeable lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Product codes (comma separated list FDA assigned to the subject device)
HQD
Device Description
The BostonSight Irregular Cornea (IC) Corneal & Scleral Lenses are lathe cut and fabricated from one of the following hydrophobic rigid gas permeable (RGP) lens materials:
- roflufocon D supplied by Contamac Ltd.
- · roflufocon E supplied by Contamac Ltd.
- · oprifocon A supplied by Bausch and Lomb, Inc.
- · hexafocon B supplied by Bausch and Lomb. Inc.
The description of the roflufocon D. roflufocon E. oprifocon A. and hexafocon B RGP materials are addressed in K033594, K022128, and K071266 respectively.
The BostonSight IC Corneal & Scleral Lenses for daily wear may be prescribed in otherwise nondiseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or following refractive (e.g. LASIK) surgery.
The BostonSight IC Scleral Lens is a large diameter RGP lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera.
The BostonSight IC Corneal & Scleral Lenses may be shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the BostonSight IC Corneal & Scleral Lenses is the Bausch & Lomb Frequent Replacement Contact Lens Case, with clearance under 510(k) K896685.
When shipped "wet". The BostonSight IC Corneal & Scleral Lenses manufactured from material supplied by Bausch & Lomb, inc. may be packaged and shipped in Boston Advance Comfort Formula Conditioning Solution (K974466) or Boston SIMPLUS Multi-Action solution (K024289). The BostonSight IC Corneal & Scleral Lenses manufactured from material supplied by Contamac, Ltd. may be packaged and shipped "wet" in in the OPTIMUM by Lobob Cleaning and Disinfecting Storage solution, with clearance under 510(k) K014162.
The physical properties of the BostonSight IC Corneal & Scleral Lenses manufactured from the various materials are as follows:
| roflufocon D | roflufocon E | oprifocon A | hexafocon B | |
|---|---|---|---|---|
| Refractive Index | 1.4333 | 1.4332 | 1.4230 | 1.4240 |
| Light Transmission (clear) | >97% | >97% | >95% | >95% |
| Light Transmission (tinted) | >90% | >90% | >90% | >83% |
| Specific Gravity | 1.166 | 1.155 | 1.24 | 1.19 |
| Oxygen Permeability (Dk) ISO/FATT Method | 100 x 10^-11 (cm²/sec) (ml O₂/ml x mm Hg @ 35°C) | 125 x 10^-11 (cm²/sec) (ml O₂/ml x mm Hg @ 35°C) | 85 x 10^-11 (cm²/sec) (ml O₂/ml x mm Hg @ 35°C) | 141 x 10^-11 (cm²/sec) (ml O₂/ml x mm Hg @ 35°C) |
| Visitint lenses contain one or more of the following color additives conforming to: 21 CFR Part 73 & 74, Subpart D | D & C Green No. 6, FD & C Red No. 17, CI Solvent Yellow 18 | D & C Green No. 6, FD & C Red No. 17, CI Solvent Yellow 18 | D&C Green No.6 and D&C Yellow No.10 | D&C Green No. 6; C.I. Solvent Yellow No. 18; D&C Violet No. 2; D&C Red No. 17; C.I. Solvent Yellow No.18 |
| UV Light Blocking (UVB - 280nm – 315nm; UVA 316nm – 380nm) | >98% UVB >95% UVA | >98% UVB >95% UVA | >95% UVB >97% UVA | >95% UVB >97% UVA |
| Dynamic Receding Contact Angle | 3° | 6° | 56° | 40° |
Lens parameters:
- 米 Chord Diameter: 8.0 mm to 26.0 mm
- 米 Center Thickness: 0.05mm to 0.60 mm
- 米 Base Curve: 5.0 mm to 9.0 mm
- 米 Spherical Powers: -25.00 Diopters to +35.00 Diopters
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes / corneal / scleral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eyecare practitioners
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)
The safety profiles for finished lenses manufactured from the roflufocon D, roflufocon A, and hexafocon B rigid gas permeable (RGP) materials are demonstrated in K033594, K071266, and K022128 respectively-which address the following areas:
- · Biocompatibility
- · Shelf Life (Wet Shipping)
- · Solution Compatibility
- Clinical Evaluation
Additionally, the following testing was performed:
Bench Testing-manufacturing verification testing was conducted to demonstrate the ability of Boston Foundation for Sight to manufacture lenses, on a repeatable basis, from supplied lens blanks to a variety of prescribed parameters. All lenses were manufactured to established finished product specifications within the ANSI Z80.20 tolerance.
Bioburden Testing-bioburden testing conducted on rigid gas permeable lenses manufactured at Boston Foundation for Sight demonstrated that the colony forming units (CFU) per lens was less than 1. which is within the established acceptance criteria of less than 100 CFU per lens.
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.
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.
K896685, K974466, K024289, K014162
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
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2016
Boston Foundation for Sight c/o Mr. Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068
Re: K153066
Trade/Device Name: BostonSight IC Corneal Lens; BostonSight IC Scleral Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid gas permeable contact lens Regulatory Class: Class II Product Code: HQD Dated: December 29, 2015 Received: December 31, 2015
Dear Mr. Andre:
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
1
(21 CFR Part 807); labeling (21 CFR: Part 801); medical device 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or 301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name BostonSight IC Corneal Lens BostonSight IC Scleral Lens
Indications for Use (Describe)
The BostonSight IC Corneal & Scleral Lenses for Daily Wear are indicated for the correction of refractive error in aphakic and not aphakic persons. The lenses may be prescribed in otherwise non-diseased eves that require a rigid gas permeable lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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: K153066 Applicant information: Date Prepared: 11/11/2015 Name: Boston Foundation for Sight Address 464 Hillside Avenue, Suite 205 Needham, MA 02494 Contact Person: Eugene A. Bonte President & CEO Phone number: 781-726-7503 Correspondent/Consultant: EyeReg Consulting, Inc. Bret Andre Phone number (503) 372-5226 Fax number (503) 419-4475
Device Information:
| Device Classification: | Class II |
|---|---|
| Classification Number: | HQD |
| Classification Name: | Lenses, Rigid Gas Permeable, Daily Wear |
| Trade Name: | BostonSight IC Corneal Lens |
| BostonSight IC Scleral Lens |
4
Purpose of Submission:
~ New Device ~
Equivalent Devices:
The BostonSight IC Corneal & Scleral Lenses for daily wear are substantially equivalent to the following predicate device(s)
Predicate device:
| Predicate device
| manufacturer | Device name | 510(k) number |
|---|---|---|
| Contamac Ltd. | OPTIMUM EXTRA (Oxygen Permeable) Daily Wear | |
| Contact Lenses (roflufocon D) | ||
| OPTIMUM EXTREME (Oxygen Permeable) Daily | ||
| Wear Contact Lenses (roflufocon E) | K033594 | |
| Bausch & Lomb, Inc. | Boston EQUALENS II (oprifocon A) | |
| Rigid Gas Permeable Contact Lenses | K022128 | |
| Bausch & Lomb, Inc. | Boston XO2 (hexafocon B) Daily Wear Contact | |
| Lens | K071266 |
Device Description:
The BostonSight Irregular Cornea (IC) Corneal & Scleral Lenses are lathe cut and fabricated from one of the following hydrophobic rigid gas permeable (RGP) lens materials:
- roflufocon D supplied by Contamac Ltd.
- · roflufocon E supplied by Contamac Ltd.
- · oprifocon A supplied by Bausch and Lomb, Inc.
- · hexafocon B supplied by Bausch and Lomb. Inc.
The description of the roflufocon D. roflufocon E. oprifocon A. and hexafocon B RGP materials are addressed in K033594, K022128, and K071266 respectively.
The BostonSight IC Corneal & Scleral Lenses for daily wear may be prescribed in otherwise nondiseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or following refractive (e.g. LASIK) surgery.
The BostonSight IC Scleral Lens is a large diameter RGP lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera.
The BostonSight IC Corneal & Scleral Lenses may be shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the BostonSight IC Corneal & Scleral Lenses is the Bausch & Lomb Frequent Replacement Contact Lens Case, with clearance under 510(k) K896685.
5
When shipped "wet". The BostonSight IC Corneal & Scleral Lenses manufactured from material supplied by Bausch & Lomb, inc. may be packaged and shipped in Boston Advance Comfort Formula Conditioning Solution (K974466) or Boston SIMPLUS Multi-Action solution (K024289). The BostonSight IC Corneal & Scleral Lenses manufactured from material supplied by Contamac, Ltd. may be packaged and shipped "wet" in in the OPTIMUM by Lobob Cleaning and Disinfecting Storage solution, with clearance under 510(k) K014162.
The physical properties of the BostonSight IC Corneal & Scleral Lenses manufactured from the various materials are as follows:
| roflufocon D | roflufocon E | oprifocon A | hexafocon B | |
|---|---|---|---|---|
| Refractive Index | 1.4333 | 1.4332 | 1.4230 | 1.4240 |
| Light Transmission | ||||
| (clear) | >97% | >97% | >95% | >95% |
| Light Transmission | ||||
| (tinted) | >90% | >90% | >90% | >83% |
| Specific Gravity | 1.166 | 1.155 | 1.24 | 1.19 |
| Oxygen | ||||
| Permeability | ||||
| (Dk) | $100 \times 10^{-11}$ | |||
| (cm²/sec) (ml O₂/ml x | ||||
| mm Hg @ 35°C) | $125 \times 10^{-11}$ | |||
| (cm²/sec) (ml O₂/ml x | ||||
| mm Hg @ 35°C) | $85 \times 10^{-11}$ | |||
| (cm²/sec) (ml O₂/ml x | ||||
| mm Hg @ 35°C) | $141 \times 10^{-11}$ | |||
| (cm²/sec) (ml O₂/ml x | ||||
| mm Hg @ 35°C) | ||||
| ISO/FATT Method | ||||
| Visitint lenses | ||||
| contain one or more | ||||
| of the following | ||||
| color additives | ||||
| conforming to: | ||||
| 21 CFR Part 73 & | ||||
| 74, Subpart D | D & C Green No. | |||
| 6, FD & C Red | ||||
| No. 17, | ||||
| CI Solvent | ||||
| Yellow 18 | D & C Green No. | |||
| 6, FD & C Red | ||||
| No. 17, | ||||
| CI Solvent | ||||
| Yellow 18 | D&C Green No.6 | |||
| and D&C Yellow | ||||
| No.10 | D&C Green No. | |||
| 6; C.I. Solvent | ||||
| Yellow No. 18; | ||||
| D&C Violet No. | ||||
| 2; D&C Red No. | ||||
| 17; C.I. Solvent | ||||
| Yellow No.18 | ||||
| UV Light Blocking | ||||
| (UVB - 280nm – | ||||
| 315nm; UVA 316nm | ||||
| – 380nm) | >98% UVB |
95% UVA | >98% UVB
95% UVA | >95% UVB
97% UVA | >95% UVB
97% UVA |
| Dynamic Receding
Contact Angle | 3° | 6° | 56° | 40° |
Lens parameters:
- 米 Chord Diameter:
- 米 Center Thickness:
- 米 Base Curve:
- 米 Spherical Powers:
8.0 mm to 26.0 mm 0.05mm to 0.60 mm 5.0 mm to 9.0 mm -25.00 Diopters to +35.00 Diopters
Indication for Use:
The BostonSight IC Corneal & Scleral Lenses for Daily Wear are indicated for the correction of refractive error in aphakic and not aphakic persons. The lenses may be prescribed in otherwise nondiseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the
6
lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Description of Safety:
The safety profiles for finished lenses manufactured from the roflufocon D, roflufocon A, and hexafocon B rigid gas permeable (RGP) materials are demonstrated in K033594, K071266, and K022128 respectively-which address the following areas:
- · Biocompatibility
- · Shelf Life (Wet Shipping)
- · Solution Compatibility
- Clinical Evaluation
Additionally, the following testing was performed:
Bench Testing-manufacturing verification testing was conducted to demonstrate the ability of Boston Foundation for Sight to manufacture lenses, on a repeatable basis, from supplied lens blanks to a variety of prescribed parameters. All lenses were manufactured to established finished product specifications within the ANSI Z80.20 tolerance.
Bioburden Testing-bioburden testing conducted on rigid gas permeable lenses manufactured at Boston Foundation for Sight demonstrated that the colony forming units (CFU) per lens was less than 1. which is within the established acceptance criteria of less than 100 CFU per lens.
~ Conclusions Drawn from Testing ~
Testing presented in this submission demonstrate no significant differences from the predicate devicessupporting the substantial equivalence claim of these BostonSight IC Corneal & Scleral Lenses to the already marketed roflufocon D. roflufocon E. oprifocon A. and hexafocon B RGP contact lenses.
Substantial Equivalence:
The BostonSight IC Corneal & Scleral Lenses for Daily Wear are substantially equivalent to the predicate devices and do not raise different questions of safety and effectiveness than the predicate devices identified previously.
~ Discussion of Similarities and Differences ~
The BostonSight IC Corneal & Scleral Lenses are identical to the predicate devices in terms of material (USAN), indications, lens design, and production method. There are no significant differences to report between the BostonSight IC Corneal & Scleral Lenses and the predicate devices.
7
The following table depicts the pre-clinical characteristics of the BostonSight IC Corneal & Scleral Lenses, as well as the predicate device.
| | BostonSight IC
Corneal & Scleral
Lenses | OPTIMUM GP
(OPTIMUM EXTRA &
OPTIMUM EXTREME) | BOSTON Equalens
II | BOSTON XO2 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device | Predicate Device | Predicate Device |
| Indication for Use | The BostonSight IC
Corneal & Scleral
Lenses for Daily Wear
are indicated for the
correction of refractive
error in aphakic and not
aphakic persons. The
lenses may be prescribed
in otherwise non-diseased
eyes that require a rigid
gas permeable lens for the
management of irregular
corneal conditions such as
keratoconus, pellucid
marginal degeneration or
following penetrating
keratoplasty or refractive
(e.g. LASIK) surgery. | The OPTIMUM GP
(roflufocon D & E)
Daily Wear Contact Lens
may be prescribed
in otherwise non-diseased
eyes that require
a rigid gas permeable lens
for the management
of irregular corneal
conditions such as;
keratoconus, pellucid
marginal degeneration
of following penetrating
keratoplasty or following
refractive (e.g. LASIK)
surgery. | The BOSTON
Equalens II may be
prescribed in otherwise
non-diseased eyes that
require a rigid contact
lens for the
management of
irregular corneal
conditions such as
keratoconus, pellucid
marginal degeneration
or following
penetrating
keratoplasty or
refractive (e.g. LASIK)
surgery. | The Boston XO2
(hexafocon B) RGP
contact lenses may be
prescribed in otherwise
non-diseased eyes that
require a rigid contact
lens for management of
irregular corneal
conditions such as
keratoconus, pellucid
marginal degeneration, or
following penetrating
keratoplasty or refractive
(e.g. LASIK) surgery. |
| Device and
Classification | Class II
Daily wear, Rigid
Gas Permeable RGP
Contact Lens
HQD | Class II
Daily wear, Rigid Gas
Permeable RGP
Contact Lens
HQD | Class II
Daily wear, Rigid
Gas Permeable
RGP Contact Lens
HQD | Class II
Daily wear, Rigid
Gas Permeable RGP
Contact Lens
HQD |
| Production Method | Lathe-cut | Lathe-cut | Lathe-cut | Lathe-cut |
| FDA Group # | Group # 3 Fluoro
Silicone Acrylate | Group # 3 Fluoro
Silicone Acrylate | Group # 3 Fluoro
Silicone Acrylate | Group # 3 Fluoro
Silicone Acrylate |
| Water Content |