FDA.reportPublic FDA data

CJ HIDROCOR CRISTAL

Primary DI
07908001923492
Brand
CJ HIDROCOR CRISTAL
Company
SOLOTICA INDUSTRIA E COMERCIO LTDA
Model
0391N-0325
Device description
Soft corrective contact lens
Published
2026-06-25
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
07908001923492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908001923492079080019234927908001923492

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep the lenses between 15 °C to 25 °C and out of direct sunlight while in the original packaging.
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+551139593500qualidade@solotica.com.br

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
07908001923270CJ HIDROCOR QUARTZO0391C-01002026-06-25
07908001923287CJ HIDROCOR QUARTZO0391C-01252026-06-25
07908001923294CJ HIDROCOR QUARTZO0391C-01502026-06-25
07908001923300CJ HIDROCOR QUARTZO0391C-01752026-06-25
07908001923317CJ HIDROCOR QUARTZO0391C-02002026-06-25
07908001923324CJ HIDROCOR QUARTZO0391C-02252026-06-25
07908001923331CJ HIDROCOR QUARTZO0391C-02502026-06-25
07908001923348CJ HIDROCOR QUARTZO0391C-02752026-06-25
07908001923355CJ HIDROCOR QUARTZO0391C-03002026-06-25
07908001923362CJ HIDROCOR QUARTZO0391C-03252026-06-25
07908001923379CJ HIDROCOR QUARTZO0391C-03502026-06-25
07908001923386CJ HIDROCOR QUARTZO0391C-03752026-06-25
07908001923393CJ HIDROCOR QUARTZO0391C-04002026-06-25
07908001923409CJ HIDROCOR CRISTAL0391N-01002026-06-25
07908001923416CJ HIDROCOR CRISTAL0391N-01252026-06-25
07908001923423CJ HIDROCOR CRISTAL0391N-01502026-06-25
07908001923430CJ HIDROCOR CRISTAL0391N-01752026-06-25
07908001923447CJ HIDROCOR CRISTAL0391N-02002026-06-25
07908001923454CJ HIDROCOR CRISTAL0391N-02252026-06-25
07908001923461CJ HIDROCOR CRISTAL0391N-02502026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908001923270CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923287CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923294CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923300CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923317CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923324CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923331CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923348CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923355CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923362CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923379CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923386CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923393CJ HIDROCOR QUARTZOSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923409CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923416CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923423CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923430CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923447CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923454CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923461CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923478CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923485CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923508CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923515CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923522CJ HIDROCOR CRISTALSOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923652CJ HIDROCOR OCRESOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923669CJ HIDROCOR OCRESOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923676CJ HIDROCOR OCRESOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923683CJ HIDROCOR OCRESOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25
07908001923690CJ HIDROCOR OCRESOLOTICA INDUSTRIA E COMERCIO LTDALPL2026-06-25