Search Results

KELOCOTE SCAR GEL: FOR THE MANAGEMENT OF HYPERTROPHIC SCARS AND KELOID SCARS AND ASSOCIATED ERYTHEMA SECONDARY TO ANY TRAUMA CAUSING SCARS KELOCOTE LASER GEL: FOR THE MANAGEMENT OF HYPERTROPHIC SCARS AND KELOID SCARS AND ERYTHEMA SECONDARY TO LASER RESURFACING

Kelocote Scar Gel and Kelocote Laser Gel are topical silicone elastomer products. Kelocote Gel is described as an amorphous paste with minimal to no elasticity or strength. Kelocote Gel in one form will contain Titanium Oxid or Zinc Oxide for color and concistency. Kelocote is manufactured from Applied Silicone's LSR-30 and or Nusil Technology's MED 4210 and 4211 Silicone Rubber MAF 612.

This document is a 510(k) premarket notification for a medical device called "Kelocote Scar Gel and Kelocote Laser Gel." The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective as a similar device already on the market and does not require premarket approval.

Based on the provided text, there is no acceptance criteria or study data presented in the format requested. The document primarily focuses on the device's intended use, physical properties, and packaging, along with the FDA's decision regarding its substantial equivalence.

Here's why the requested information cannot be extracted:

• Acceptance Criteria and Device Performance: The document states that Kelocote Scar Gel and Kelocote Laser Gel are "substantially equivalent" to Kelocote Gel of Allied Biomedical, which was in turn found "SE to PMT's Gel Sheeting." This is the basis for market clearance, not specific performance metrics or acceptance criteria for a new study. There are no tables of performance metrics.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Study, Training Set Information: Since no new performance study is described, none of this information (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details) is available in the provided text. The FDA's substantial equivalence determination rarely requires new clinical trials if equivalence can be demonstrated through other means (e.g., comparison to a predicate device's characteristics and historical use).

In summary, the document is an FDA clearance letter based on substantial equivalence, not a report of a performance study with acceptance criteria.

Ask a specific question about this device