510(k) · Cleared
ClearedMicrocyn Plus Skin and Wound Hydrogel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oculus Innovative Sciences · FRO Dressing, Wound, Drug
Cleared on Apr 19, 2016 as substantially equivalent to K093585 (Oculus Innovative Sciences, Inc., 2010) and 1 other predicate after a 120-day review. Its family tree reaches back 5 generations to 1983. 6 later devices descend from it.
- Decided
- Apr 19, 2016
- Review
- 120 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K830708 (1983). 13 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK830708 Duo Derm Flex Hydroactive Dressings &Convatec, A Division of E.R. Squibb & Sons · 1983
- 4 generations backK984413 Bionect HydrogelFidia Pharmaceutical Corp. · 1999
- 3 generations backK020325 L.a.M. Ipm Wound GelL.A.M. Pharmaceutical, Corp. · 2002
- 2 generations backK090725 Oculus Microcyn Wound GelOculus Innovative Sciences, Inc. · 2009
- 1 generation backK093585 Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc. · 2010 · Recalled
- This deviceK153648 Microcyn Plus Skin and Wound HydrogelOculus Innovative Sciences · 2016
- Descendant · cites it directly · 4 of its ownK173549 BiafineValeant Pharmaceuticals · 2018
- Descendant · 2 generations on · 2 of its ownK232655 Bonvadis®Stemcyte, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK251093 Bonvadis®Oneness Biotech Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK261638 Bonvadis®Oneness Biotech Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK190342 BIAFINE Topical CreamBausch Health Americas Incorporated · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K173549BiafineValeant Pharmaceuticals · 2018 · cites it directly4descendants
- K232655Bonvadis®Stemcyte, Inc. · 2024 · 2 generations on2descendants
- K251093Bonvadis®Oneness Biotech Co., Ltd. · 2025 · 2 generations on1descendant
- K261638Bonvadis®Oneness Biotech Co., Ltd. · 2026 · 3 generations on0descendants
- K190342BIAFINE Topical CreamBausch Health Americas Incorporated · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K830708 | Duo Derm Flex Hydroactive Dressings & | Convatec, A Division of E.R. Squibb & Sons | 1983 | — |
| −4 | K984413 | Bionect Hydrogel | Fidia Pharmaceutical Corp. | 1999 | — |
| −3 | K020325 | L.a.M. Ipm Wound Gel | L.A.M. Pharmaceutical, Corp. | 2002 | — |
| −2 | K090725 | Oculus Microcyn Wound Gel | Oculus Innovative Sciences, Inc. | 2009 | — |
| −1 | K093585 | Microcyn Skin and Wound Hydrogel | Oculus Innovative Sciences, Inc. | 2010 | 1 |
| 0 (this device) | K153648 | Microcyn Plus Skin and Wound Hydrogel | Oculus Innovative Sciences | 2016 | — |
| +1 | K173549 | Biafine | Valeant Pharmaceuticals | 2018 | — |
| +2 | K232655 | Bonvadis® | Stemcyte, Inc. | 2024 | — |
| +2 | K251093 | Bonvadis® | Oneness Biotech Co., Ltd. | 2025 | — |
| +3 | K261638 | Bonvadis® | Oneness Biotech Co., Ltd. | 2026 | — |
| +2 | K190342 | BIAFINE Topical Cream | Bausch Health Americas Incorporated | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRO device
- #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K093585 | Microcyn Skin and Wound HydrogelSummary page 4…Regulatory Class: Unclassified, Pre-amendment status Product Code: FRO III. PREDICATE DEVICE Microcyn Skin and Wound Gel manufactured by Oculus Innovative Sciences (K093585) Sockit Dermal Wound Gel manufactured by McMerlin Dental Products (K090092) IV. DEVICE DESCRIPTION The Microcyn Plus Skin an… | 2010 |
| * | K090092 | Sockit! and Mcmerlin Dermal Wound GelSummary page 4…I. PREDICATE DEVICE Microcyn Skin and Wound Gel manufactured by Oculus Innovative Sciences (K093585) Sockit Dermal Wound Gel manufactured by McMerlin Dental Products (K090092) IV. DEVICE DESCRIPTION The Microcyn Plus Skin and Wound Hydrogel is a clear gel, slightly chlorinated odor, viscous gel. Th… | 2009 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K173549 (Valeant Pharmaceuticals, 2018) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K093585.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
Rx Indications for Use: Under the supervision of a health care professional Microcyn Plus Skin and Wound Gel is intended for the management of post non ablative laser therapy procedures, post microdermabrasion therapy and following superficial chemical peels. Microcyn Plus Wound Gel may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns. OTC Indications for Use: Microcyn Plus Skin and Wound Gel is…
Read the full statement (116 words)
Rx Indications for Use:
Under the supervision of a health care professional Microcyn Plus Skin and Wound Gel is intended for the management of post non ablative laser therapy procedures, post microdermabrasion therapy and following superficial chemical peels. Microcyn Plus Wound Gel may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns.
OTC Indications for Use:
Microcyn Plus Skin and Wound Gel is intended for the management of minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. Microcyn Plus Skin and Wound Gel may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153648: Microcyn Plus Skin and Wound Hydrogel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153648
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026