(123 days)
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear 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 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber.
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens for daily wear is made available in spherical, toric, multifocal, scleral and aspheric designs in the following lens parameters:
| Parameter | Range | Tolerance |
|---|---|---|
| Base Curve | 4.00mm to 11.5mm | ± 0.05 mm |
| Center Thickness | 0.08mm to 0.75mm | ± 0.02 mm |
| Diameter | 7.0mm to 21.0mm | ±0.10mm |
| Spherical Power | -20.00D to +20.00D | ± 0.12 (0 to = 5D) ± 0.18 (5 to = 10.0D) ± 0.25 (10 to = 15D) ± 0.37 (15 to = 20D) ± 0.50 (over 20D) |
| Cylindrical Power | Up to 9.00D | ± 0.25 (0 to = 2D) ± 0.37 (2 to = 4D) ± 0.50 (over 4D) |
| Multifocal Power | +1.00D to 4.00D | ± 0.25D |
| Surface Appearance | Lenses should be clear with no surfacedefect |
The following table depicts the physical properties of the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens:
| Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | |
|---|---|
| Refractive Index | 1.430 |
| Modulus (MPa) | 1194 |
| Hardness (Shore D) | 78 |
| Specific Gravity | 1.18 |
| Oxygen Permeability(Dk) | 200 x 10⁻¹¹ (cm²/sec) (ml O₂/ml x mm Hg @ 35 °C) |
| Color Additives | Visibility Tints – D&C Green #6, D&C Violet #2, Solvent Yellow 18, D&C Red #17 |
This document describes the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens and its substantial equivalence to predicate devices, focusing on its expanded indications for use.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics like accuracy, sensitivity, or specificity, as it's a 510(k) submission for a medical device (contact lens) and not an AI/software device. The primary "acceptance criteria" for such a device effectively revolve around demonstrating substantial equivalence to legally marketed predicate devices and proving its safety and effectiveness for its intended use and expanded indications.
The reported device performance is primarily qualitative and based on the outcomes of a retrospective clinical study.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness for Original Indications | Demonstrated through previous 510(k) clearances. Substantial equivalence to predicate for its original indications (correction of refractive error in non-diseased eyes). |
| Safety and Effectiveness for Expanded Indications | In a retrospective clinical study (41 patients, 66 eyes), "irregular corneal conditions and vision remained stable or improved during treatment with the Acuity 200 (fluoroxyfocon A) contact lenses." No serious adverse reactions reported over 13,760 total days of wear. This demonstrates safety and effectiveness for management of irregular corneal conditions. |
| Physical and Chemical Properties Equivalence | Refractive Index, Modulus, Hardness, Specific Gravity, and Oxygen Permeability (Dk) are provided for the Acuity 200 and are comparable to predicate devices in terms of material group. |
| Manufacturing and Design Equivalence | Lathe-cut production method, daily wear intended use, <1% water content, and UV absorber availability are equivalent to predicate devices. |
| Material Equivalence | Same USAN material (fluoroxyfocon A) as one predicate, and within the same FDA material group (Group #3 Fluoro Silicone Acrylate) as all predicates. |
| Compliance with General Controls and Regulations | Implicitly met as part of the 510(k) clearance process. |
2. Sample size used for the test set and the data provenance
- Sample Size: 41 patients (66 total eyes).
- Data Provenance: The data was obtained from a retrospective review of medical charts. The country of origin of the data is not explicitly stated, but the submitter (Acuity Polymers, Inc.) is based in Rochester, NY, United States.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Four (4) independent practitioners.
- Qualifications of Experts: The document refers to them as "independent practitioners" but does not specify their exact qualifications (e.g., ophthalmologists, optometrists, or years of experience).
4. Adjudication method for the test set
- The document does not specify an adjudication method. It states that "Four (4) independent practitioners retrospectively reviewed medical charts," but it does not detail how potential discrepancies or disagreements among these practitioners were resolved or if their findings were aggregated. It appears each practitioner's assessment of their own patients' outcomes was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This is a contact lens submission, not an AI-assisted diagnostic or interpretative device. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The Acuity 200™ is a physical medical device (contact lens) and does not involve any algorithm or AI for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth was based on clinical outcomes data derived from the medical charts reviewed by the independent practitioners. Specifically, it focused on whether "irregular corneal conditions and vision remained stable or improved."
8. The sample size for the training set
- Not applicable. This device is a physical contact lens, not a machine learning or AI model. Therefore, there is no "training set" in the context of algorithm development. The safety and effectiveness of the material and design were established through previous clearances and the clinical study mentioned.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an algorithm, this question is not relevant to this device submission.
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April 9, 2021
Acuity Polymers, Inc. % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Lane West Linn. OR 97068
Re: K203571
Trade/Device Name: Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: March 1, 2021 Received: March 8, 2021
Dear Bret 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
J Angelo Green -S
J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203571
Device Name
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
Indications for Use (Describe)
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with nondiseased eyes. The lenses may be prescribed for daily wear 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 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and disinfected using a chemical (not heat) lens care system.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510 (k) SUMMARY
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:
I. SUBMITTER
| Date Prepared: | April 7th, 2021 |
|---|---|
| Name:Address: | Acuity Polymers, Inc.1667 Lake Avenue, Suite 354Rochester, NY 14615United States |
| Contact Person:Phone number: | James A. Bonafini, JrPresident(585) 458-8409 |
| Consultant: | Bret AndreEyeReg Consulting, Inc.6119 Canter Ln.West Linn, OR 97068 |
| Phone number: | (503) 372-5226 |
II. DEVICE
| Trade Name: | Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens |
|---|---|
| CommonName: | Daily wear rigid gas permeable contact lens |
| ClassificationName: | Rigid gas permeable contact lens. (21 CFR 886.5916) |
| RegulatoryClass: | Class II |
| Product Code: | HQD |
| New Indications for Use |
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III. PREDICATE DEVICE
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens for daily wear is substantially equivalent to the following predicate devices:
- "Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens" ■ By Acuity Polymers, Inc. 510(k) number; K201194
- 트 "BostonSight PD Prosthetic Device" Manufactured by Boston Foundation for Sight 510(k) number; K161461
- I "Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)" By Art Optical Contact Lens, Inc. 510(k) number; K172314
IV. DEVICE DESCRIPTION
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber.
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens for daily wear is made available in spherical, toric, multifocal, scleral and aspheric designs in the following lens parameters:
| Parameter | Range | Tolerance |
|---|---|---|
| Base Curve | 4.00mm to 11.5mm | ± 0.05 mm |
| Center Thickness | 0.08mm to 0.75mm | ± 0.02 mm |
| Diameter | 7.0mm to 21.0mm | ±0.10mm |
| Spherical Power | -20.00D to +20.00D | ± 0.12 (0 to = 5D)<br ± 0.18 (5 to = 10.0D)<br ± 0.25 (10 to = 15D)<br ± 0.37 (15 to = 20D)<br ± 0.50 (over 20D) |
| Cylindrical Power | Up to 9.00D | ± 0.25 (0 to = 2D)<br ± 0.37 (2 to = 4D)<br ± 0.50 (over 4D) |
| Multifocal Power | +1.00D to 4.00D | ± 0.25D |
| Surface Appearance | Lenses should be clear with no surfacedefect |
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The following table depicts the physical properties of the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens:
| Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | |
|---|---|
| Refractive Index | 1.430 |
| Modulus (MPa) | 1194 |
| Hardness (Shore D) | 78 |
| Specific Gravity | 1.18 |
| Oxygen Permeability(Dk) | $200 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35 °C) |
| Color Additives | Visibility Tints – D&C Green #6, D&C Violet #2, Solvent Yellow 18, D&C Red #17 |
V. INDICATIONS FOR USE
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear 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 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and disinfected using a chemical (not heat) lens care system.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is substantially equivalent to the predicate devices (cleared under K201194, K161461, and K172314) in terms of the following:
- Intended use daily wear contact lenses 트
- 트 Indications for use
- o Management of Irregular Corneal Conditions
- Correction of Refractive Error o
- 트 Actions
- Classification - Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916)
- 트 FDA material group - group # 3 fluoro silicone acrylate
- USAN material (fluoroxyfocon A)
- 트 Production method - lathe cut
- 트 Final packaging and shipping
The following matrix illustrates the production method. lens function and material characteristics of the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, as well as the predicate device.
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| Acuity 200TM(fluoroxyfocon A)Rigid GasPermeableContact Lens | Acuity 200TM(fluoroxyfoconA) Rigid GasPermeableContact Lens | BostonSight PDProstheticDevice | Ampleye Scleral RGPLens (roflufocon D,roflufocon E,hexafocon A,paflufocon D) | |
|---|---|---|---|---|
| Subject Device | Predicate Device(K201194) | PredicateDevice(K161461) | Predicate Device(K172314) | |
| Classification | Class IILenses, Rigid GasPermeable, DailyWear21 CFR 886.5916 | Class IILenses, Rigid GasPermeable, DailyWear21 CFR 886.5916 | Class IILenses, RigidGas Permeable,Daily Wear21 CFR886.5916 | Class IILenses, Rigid GasPermeable, Daily Wear21 CFR 886.5916 |
| Product Code | HQD | HQD | HQD | HQD |
| FDA Group # | Group # 3 FluoroSilicone Acrylate | Group # 3 FluoroSilicone Acrylate | Group # 3Fluoro SiliconeAcrylate | Group # 3 FluoroSilicone Acrylate |
| Material (USAN) | fluoroxyfocon A | fluoroxyfocon A | roflufocon D,roflufocon E,oprifocon A,and hexafoconB | roflufocon D,roflufocon E,hexafocon A,paflufocon D |
| ProductionMethod | Lathe-Cut | Lathe-Cut | Lathe-Cut | Lathe-Cut |
| Intended Use | Daily Wear | Daily Wear | Daily Wear | Daily Wear |
| Water Content(%) | <1% | <1% | <1% | <1% |
| UV AbsorberAvailable | Yes | Yes | Yes | Yes |
Substantial Equivalence Matrix
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| Indications for Use | |
|---|---|
| Acuity 200TM(fluoroxyfoconA) Rigid GasPermeableContact Lens(Subject Device) | The Acuity 200TM (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear forthe correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic andnon-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwisenon-diseased eyes that require a rigid contact lens for the management of irregular corneal conditionssuch as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive(e.g., LASIK) surgery.The Acuity 200TM (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned anddisinfected using a chemical (not heat) lens care system. |
| Acuity 200TM(fluoroxyfoconA) Rigid GasPermeableContact Lens(K201194) | The Acuity 200TM (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wearfor the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic andnon-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical and asphericpowers ranging from -20.00 D to +20.00 D for daily wear. |
| BostonSight PDProsthetic Device(K161461) | The Boston Sight PD Prosthetic Device for daily wear is indicated for therapeutic use for themanagement of a distorted corneal surface that:1. precludes satisfactory spectacle lens correction2. demonstrates significant improved rigid contact lens corrected vision3. is incapable of wearing traditional corneal lenses because of the inability to achieve adequatelens centration/stability and/or tolerance to physical contact with a lensCauses of corneal distortion include corneal degeneration (e.g. keratoconus, keratoglobus, pellucidmarginal degeneration, Salzmann's nodular degeneration), corneal dystrophy (e.g, lattice dystrophy,Reis-Bucklers dystrophy), and scarring from surgery (e.g. corneal transplant, LASIK, radialkeratotomy), infection, or trauma.The BostonSight PD Prosthetic Device for daily wear is also indicated for therapeutic use in eyes withocular surface disease from dry eye (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eyesyndrome), limbal stem cell deficiency (e.g.Stevens-Johnson syndrome, chemical and thermal burns,radiation), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpessimplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) thatmight benefit from the presence of an expanded tear reservoir and protection against an adverseenvironment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, theBostonSight PD Prosthetic Device may incidentally provide correction of refractive error.The BostonSight PD Prosthetic Device may be cleaned and disinfected using a chemical (not heat)care system. |
| Ampleye ScleralRGP Lens(roflufocon D,roflufocon E,hexafocon A,paflufocon D)(K172314) | The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) for dailywear is indicated for use for the management of irregular astigmatism, corneal degeneration ordystrophy caused by keratoconus, keratoglobus, pellucid marginal degeneration (PMD), post cornealtrauma/scaring, post keratoplasty, post K-Pro, post RK, post PRK, post LASIK, Salzmann's nodulardegeneration, Cogan's dystrophy, granular corneal dystrophy, lattice corneal dystrophy or Reis-Bucklersdystrophy.The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is alsoindicated for therapeutic management of ocular surface disease from dry eye including ocularpemphigoid, Stevens-Johnson syndrome, symblepharon formation, graft vs host disease, persistentepithelial defect, exposure keratitis, neurotrophic keratopathy( herpes simplex, herpes zoster, familialdysautonomia), Sjögren's syndrome, filamentary keratitis, limbal stem cell deficiency, atopy,ectodermal dysplasia. When prescribed for therapeutic use for irregular astigmatism or ocular surfacediseases, the Ampleye Scleral RGP Lens may also provide correction of refractive error includingmyopia, hyperopia, presbyopia and regular astigmatism.Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning,disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, thelens may be cleaned and disinfected using a chemical (not heat) lens care system. |
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VII. PERFORMANCE DATA
~ Non-Clinical Studies ~
Non-clinical testing to demonstrate the safety and effectiveness of the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens has been addressed through previously cleared 510(k) premarket notifications.
~ Clinical Studies ~
Four (4) independent practitioners retrospectively reviewed medical charts of 41 patients (66 total eyes) presenting with irregular corneal conditions that were managed using contact lenses manufactured from Acuity 200 (fluoroxyfocon A) material. For all patients, the irregular corneal conditions and vision remained stable or improved during treatment with the Acuity 200 (fluoroxyfocon A) contact lenses. The successful fitting of 66 eyes over a total of 13,760 days without any serious adverse reaction reported demonstrate the Acuity 200 (fluoroxyfocon A ) contact lenses are safe and effective for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.
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VIII. CONCLUSIONS
Substantial Equivalence
Information presented in this premarket notification establishes that the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens for daily wear is as safe and effective as the predicate devices when used in accordance with the labeled directions for use and for the proposed indications.
Risks and Benefits
The risks of the subject device are the same as those normally attributed to the wearing of rigid gas permeable (RGP) daily wear contact lenses. The benefits to the patient are the same as those for other RGP contact lenses.
§ 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.