FDA.reportPublic FDA data

HIDROCOR COPACABANA -00,00

Primary DI
07908001984004
Brand
HIDROCOR COPACABANA -00,00
Company
SOLOTICA INDUSTRIA E COMERCIO LTDA
Model
038220-0000
Device description
Soft corrective contact lens, daily-wear - Hidrocor Copacabana
Published
2026-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPLLenses, soft contact, daily wear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPLLenses, Soft Contact, Daily WearOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160472000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160472000Hidrocor, Hidrocharme, and Natural ColorsSolotica2016-08-10LPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07908001984004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908001984004079080019840047908001984004

GMDN Terms#

Term, Definition table
TermDefinition
Soft corrective contact lens, daily-wearA soft ophthalmic lens intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct refractive vision conditions that occur naturally (e.g., myopia, hyperopia, astigmatism, presbyopia) or post surgery; it is designed to be removed prior to sleeping each night. The device may be coloured/tinted for easier handling or to change the appearance of the eye for cosmetic purposes; it may include an ultraviolet blocker. The device is made of various synthetic polymer materials, the main polymer molecules being hydrophilic (e.g., hydrogel); it permits diffusion of oxygen (O2) to the ocular surface. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-9999xx@xx.xx

Regulatory Flags#

DUNS number
899767974
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07908001983953HIDROCOR BUZIOS -00,00038210-00002026-06-05
07899031699962Hidrocor Verde03821-00002026-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908001983953HIDROCOR BUZIOS -00,00SOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-05
07899031699962Hidrocor VerdeSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-05-11
08800071415442Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
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