SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens, SynergEyes UltraHealth for Keratoconus (petrafocon A hem-larafilcon A) Hybrid Daily Wear Co

K153714 · Synergeyes, Inc. · HQD · Nov 15, 2016 · Ophthalmic

Device Facts

• Record ID: K153714
• Device Name: SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens, SynergEyes UltraHealth for Keratoconus (petrafocon A hem-larafilcon A) Hybrid Daily Wear Co
• Applicant: Synergeyes, Inc.
• Product Code: HQD · Ophthalmic
• Decision Date: Nov 15, 2016
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 886.5916
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SynergEyes™ A (paflufocon D hem-iberfilcon A) and SynergEyes™ M (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses are indicated for use in the correction of hyperopic, and astigmatic refractive error including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicted for the correction of up to +20.00 and -20.00 D in eves with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional. SynergEyes™ KC (paflufocon D hem-iberfilcon D) and ClearKone™ (paflufocon D hem-iberfilcon A) Daily Wear Hybrid Contact Lenses for keratoconus are in the correction of eyes with refractive errors that include hyperopia and myopia that manifest irregular astigmatism, in aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional. SynergEyes™ PS (paflufocon A hem-iberfilcon A) Hybrid Contact Lenses are indicated for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and irregular astigmatism in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional. Duette™ (SiH) (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic, and astigmatic refractive error including presbyopia, in aphakic, nondiseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat), prior to reinsertion, as recommended by the eye care professional. UltraHealth™ (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for keratoconus are indicated for the correction of hyperopic, myopic and astigmatic refractive error including presbyopia that manifest irregular corneas or irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional. UltraHealth™ Flat Cornea SiH (petrafocon A) Hybrid Contact Lenses are for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and irregular astigmatism in aphakic and not aphakic, non-diseased eyes, with or without presbyopia. The lenses are indicated for daily wear for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular assigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

Device Story

Hybrid contact lenses consisting of rigid gas permeable center and soft skirt; designed for daily wear; prescribed by eye care professionals for refractive error correction; patient removes lenses for chemical cleaning/disinfection; provides visual correction for patients with keratoconus, irregular corneas, post-surgical/trauma eyes, and presbyopia.

Technological Characteristics

Hybrid contact lenses; materials include paflufocon D, hem-iberfilcon A, paflufocon A, petrafocon A, and hem-larafilcon A; rigid gas permeable center with soft skirt; daily wear; chemical disinfection required.

Indications for Use

Indicated for correction of hyperopic, myopic, and astigmatic refractive errors (including presbyopia, irregular astigmatism, and post-surgical/trauma cases) in aphakic and non-aphakic, non-diseased eyes. Power range +/- 20.00 D; astigmatism up to 6.00 D. Presbyopia add powers +1.00 to +4.00 D.

Regulatory Classification

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 15, 2016

Synergeyes, Inc. % Richard Lippman, OD, FAAO Regulatory Consultant R.E. Lippman Regulatory Pathways 1171 Kersey Road Silver Spring, MD 20902

Re: K153714

Trade/Device Name: SynergEyes™ A&M Hybrid Contact Lenses SynergEyes™ KC and ClearKone™ Hybrid Contact Lenses SynergEyesTM PS Hybrid Contact Lenses SynergEyes™ Duette (SiH) Hybrid Contact Lenses SynergEyesTM Ultrahealth™ Hybrid Contact Lenses for Keratoconus Hybrid Contact Lenses SynergEyes™ Ultrahealth™ Flat Cornea Hybrid Contact Lenses for Keratoconus

Regulation Number: 21 CFR 886.5926 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: September 30, 2016 Received: October 7, 2016

Dear Dr. Lippman:

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

{1}------------------------------------------------

found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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

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 [phone] or [phone] 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}------------------------------------------------

510(k) Number (if known) K153714

## Device Name

## SynergEyes™ A & M Hybrid Contact Lenses

Indications for Use (Describe)

SynergEyes™ A (paflufocon D hem-iberfilcon A) and SynergEyes™ M (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses are indicated for use in the correction of hyperopic, and astigmatic refractive error including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicted for the correction of up to +20.00 and -20.00 D in eves with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

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)

{3}------------------------------------------------

510(k) Number (if known)

#### K153714

Device Name

### SynergEves™ KC and ClearKone™ Hybrid Contact Lenses

Indications for Use (Describe)

SynergEyes™ KC (paflufocon D hem-iberfilcon A) and ClearKone™ (paflufocon D hem-iberfilcon A) Daily Wear Hybrid Contact Lenses for keratoconus are in the correction of eyes with refractive errors that include hyperopia and myopia that manifest irregular astigmatism, in aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

| 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 SubpartC)

{4}------------------------------------------------

510(k) Number (if known)

#### K153714

Device Name

### SynergEves™ PS Hybrid Contact Lenses

#### Indications for Use (Describe)

SynergEyes™ PS (paflufocon A hem-iberfilcon A) Hybrid Contact Lenses are indicated for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and irregular astigmatism in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

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 SubpartC)

{5}------------------------------------------------

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

#### K153714

Device Name

## SynergEyes™ Duette (SiH) Hybrid Contact Lenses

#### Indications for Use (Describe)

Duette™ (SiH) (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic, and astigmatic refractive error including presbyopia, in aphakic, nondiseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat), prior to reinsertion, as recommended by the eye care professional.

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 SubpartC)

{6}------------------------------------------------

510(k) Number (if known)

#### K153714

Device Name

## SynergEyes™ UltraHealthTM Hybrid Contact Lenses for Keratoconus Contact Lenses

#### Indications for Use (Describe)

UltraHealth™ (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for keratoconus are indicated for the correction of hyperopic, myopic and astigmatic refractive error including presbyopia that manifest irregular corneas or irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

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 SubpartC)

{7}------------------------------------------------

510(k) Number (if known) K153714

Device Name

## SynergEyes™ UltraHealth™ Flat Cornea Hybrid Contact Lenses for Keratoconus

#### Indications for Use (Describe)

UltraHealth™ Flat Cornea SiH (petrafocon A) Hybrid Contact Lenses are for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and irregular astigmatism in aphakic and not aphakic, non-diseased eyes, with or without presbyopia. The lenses are indicated for daily wear for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular assigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

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 )