Gelzone
by Implantech Associates, Inc.
510(k) K013732
Gelzone is a medical device (FDA Class I; FDA product code MDA, Elastomer, Silicone, For Scar Management) made by Implantech Associates, Inc., cleared under FDA 510(k) K013732 on 7 Feb 2002, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013732 | Date7 Feb 2002 | StatusActive |
Official records
- FDA 510(k) database K013732
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MDA
- Device class
- Class I
- Regulation
- 21 CFR Part 878.4025
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K013732
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Gelzone Wrap 10 cm x 30 cm (4 in x12 in) | WRAP-412 / 10 cm x 30 cm (4 in x12 in) | M724WRAP4121 | — | On the market |
| Gelzone Wrap 10 cm x 61 cm (4 in x 24 in) | WRAP-424 / 10 cm x 61 cm (4 in x 24 in) | M724WRAP4241 | — | On the market |
| Gelzone Wrap 10cm x102 cm (4 in x 40 in) | WRAP-440 / 10cm x102 cm (4 in x 40 in) | M724WRAP4401 | — | On the market |
| Gelzone Wrap 15cm x122cm (6 in x 48 in) | WRAP-648 / 15cm x122cm (6 in x 48 in) | M724WRAP6481 | — | On the market |
| Gelzone Wrap 16 cm x122 cm (6 in x48 in) | WRAP-648-NL / 16 cm x122 cm (6 in x48 in) | M724WRAP648NL1 | — | On the market |
| Gelzone Wrap 2.5 cm X 30 cm (1 in x12 in) | WRAP-112 / 2.5 cm X 30 cm (1 in x12 in) | M724WRAP1121 | — | On the market |
| Gelzone Wrap 25cm x122cm (10 in x48 in) | WRAP-1048-NL / 25cm x122cm (10 in x48 in) | M724WRAP1048NL1 | — | On the market |
| Gelzone Wrap 25cmx122cm (10 in x 48 in) | WRAP-1048 / 25cmx122cm (10 in x 48 in) | M724WRAP10481 | — | On the market |
| Gelzone Wrap 5 cm x 30 cm (2 in x12 in) | WRAP-212 / 5 cm x 30 cm (2 in x12 in) | M724WRAP2121 | — | On the market |
| Gelzone Wrap 5 cm x 41 cm (2 in x16 in) | WRAP-216 / 5 cm x 41 cm (2 in x16 in) | M724WRAP2161 | — | On the market |
Similar devices
Other devices filed under FDA product code MDA (Elastomer, Silicone, For Scar Management).
- CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL. by Smith & Nephew, Inc.
- BLAINE SCARCARE PATCH by Blaine Labs, Inc.
- DURASIL (MODIFICATION) by The S. F. Group, Inc.
- JOBSKIN CONTINUING CARE by Jobst Institute, Inc.
- SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING by Library Medical, Inc.
- VINYL SILICONE ELASTOMER MATERIAL by CROWN DELTA CORP.
- KELOCATE SHEETING by Allied Biomedical Corp.
- MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030. by Medtrade Products, Ltd.
- KELOCOTE SCAR GEL AND KELOCOTE LASER GEL by Hanson Medical, Inc.
- REJUVENESS by Rejuveness Pharamceuticals, Inc.