510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Synergeyes, Inc.

Carlsbad, CA, US

SYNERGEYES, INC. appears in FDA device records in Carlsbad, CA. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
11
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 11 510(k) clearances for Synergeyes, Inc. between 2005 and 2016. The busiest year on record is 2005, with 2. The most recent is 2016, with 2.

Clearances by year, as a table
510(k) clearance decisions for Synergeyes, Inc., by decision year
YearClearances
20052
20062
20082
20091
20121
20141
20162
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K153714SynergEyes 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 CoHQDSubstantially Equivalent
K160938SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear LensHQDSubstantially Equivalent
K142510UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact LensHQDSubstantially Equivalent
K113586SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENSHQDSubstantially Equivalent
K083921SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENSHQDSubstantially Equivalent
K081034SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PSHQDSubstantially Equivalent
K080193SYNERGEYES HYBRID CONTACT LENSES-DAILY WEARHQDSubstantially Equivalent
K061120SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSESHQDSubstantially Equivalent
K060102SYNERGEYES PS HYBRID CONTACT LENSHQDSubstantially Equivalent
K052675SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUSHQDSubstantially Equivalent
K051035SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENSHQDSubstantially Equivalent

Registered establishments

FDA registered establishments for Synergeyes, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30050876453005087645SYNERGEYES, INC.2232 Rutherford Rd, CARLSBAD, CA 92008 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Synergeyes, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain