Company ยท US
Oculus Innovative Sciences
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2017. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 23, 2017 | K162217 | LOYON Oculus Innovative Sciences | FRO |
| Aug 19, 2016 | K161034 | Microcyn Plus Wound Care Solution Oculus Innovative Sciences | FRO |
| Apr 19, 2016 | K153648 | Microcyn Plus Skin and Wound Hydrogel Oculus Innovative Sciences | FRO |
| Dec 15, 2015 | K152945 | Alevicyn SG Antipruritic Gel Oculus Innovative Sciences | FRO |
| Nov 23, 2015 | K152055 | Ceramax Skin Barrier Cream Oculus Innovative Sciences | FRO |
| Jun 4, 2015 | K143590 | Alevicyn SG Antipruritic Gel Oculus Innovative Sciences | FRO |
| Aug 18, 2014 | K141352 | ENDOCYN ROOT CANAL IRRIGATION SOLUTION Oculus Innovative Sciences | KJJ |
| Aug 8, 2014 | K141012 | HYDROCLEANSE WOUND CARE SOLUTION Oculus Innovative Sciences | FRO |
| Nov 15, 2013 | K131672 | MICROCYN SCAR MANAGEMENT HYDROGEL Oculus Innovative Sciences | PFP |
| Feb 2, 2011 | K102945 | PEDIACYN ATOPIC DERMATITIS HYDROGEL Oculus Innovative Sciences, Inc. | FRO |
| Mar 8, 2010 | K093585 | MICROCYN SKIN AND WOUND HYDROGEL Oculus Innovative Sciences, Inc. | FRO |
| Jun 2, 2009 | K090206 | OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER Oculus Innovative Sciences, Inc. | FRO |
| May 20, 2009 | K090725 | OCULUS MICROCYN WOUND GEL Oculus Innovative Sciences, Inc. | FRO |
| Feb 22, 2006 | K060113 | DERMACYN WOUND CARE Oculus Innovative Sciences, Inc. | FRO |
| May 17, 2005 | K042729 | DERMACYN WOUND IRRIGATION Oculus Innovative Sciences, Inc. | FRO |
| May 3, 2005 | K041161 | MICROCYN WOUND CARE DRESSING Oculus Innovative Sciences, Inc. | FRO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2016 | Oculus Innovative Sciences, Inc. Ceramax Skin Barrier Cream:
NET WT 0.1 OZ (3 g professional sample - not for retail sale)
Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care pr Terminated |
FRO | K152055 |
| Feb 26, 2013 | Oculus Innovative Sciences Inc Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz..
RX only, Professional Sample, Not for Sale.
Pre-printed tube: MS31071,
Shelf carton: PL51091-08
Atrapro Antipruritic HydroGel is ind Terminated |
FRO | K012945 |
| Jan 11, 2012 | Oculus Innovative Sciences Inc Microcyn Dermatology HydroGel, Spray , 4 oz and 1.76 oz.
Provided Pain Relief, Relieve Itch, Reduces symptoms of inflammation due to irritation, Provide a protective shield against contamination.
Anti Terminated |
FRO | K093585 |
| Jan 11, 2012 | Oculus Innovative Sciences Inc Microcyn Dermatology Spray with germ killing Preservatives (Rx); 8 fl oz.
99.999% Reduction In-solution in 30 seconds.
MRSA - Staphylococcus aureus
VFR - Enterococcus faecalis
Acinetobacter baumannii
Terminated |
FRO | K041161 K090206 |
| Jan 11, 2012 | Oculus Innovative Sciences Inc Puracyn OTC;
Wound & Skin Care Solution with Preservatives; Sold in 8 fl oz (trigger spray and finder pump) and 16 fl oz pump with insert.
Kills 99.99% of Staph, MRSA, Strep and other Infectious Germ Terminated |
FRO | K090206 |
| Jan 11, 2012 | Oculus Innovative Sciences Inc Microcyn Solution with Preservatives (Rx), 16.9 fl oz (500 mL) and 33.5 fl oz. (990 mL)
Ingredients: Electrolyzed Water (99.97%) Sodium Chloride (NaCl) (230 mg/L) and preservatives: Sodium Hypochlorit Terminated |
FRO | K041161 K090206 |