Identifiers
- 510(k) Number
- K191166 FDA 510(k)
- FDA Product Code
- PMC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4360 FDA 510(k)
- Regulation Number
- 878.4360 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The DigniCap Delta is a Scalp Cooling System, a device designed to reduce scalp temperature during chemotherapy to help prevent hair loss. It consists of a thermoelectric cooling unit with an integrated control system operated via touch screen monitor, which circulates temperature-controlled coolant through a hose to a Cooling Wrap containing fluid channels.
The device is supplied as a reusable system comprising a Cooling Unit, Cooling Wrap, and Thermal Cap. It is intended for use in clinical settings under professional supervision. Authorization is based on FDA 510(k) clearance (K191166) as a substantially equivalent device, classified as Class II under regulation number 878.4360, with product code PMC.
Frequently asked questions
What is the DigniCap Delta Scalp Cooling System used for?
The DigniCap Delta is a device designed to reduce scalp temperature during chemotherapy treatments to help prevent hair loss. It consists of a thermoelectric cooling unit with an integrated control system that circulates temperature-controlled coolant through a Cooling Wrap.
How is the DigniCap Delta supplied and is it reusable?
The DigniCap Delta is supplied as a reusable system comprising a Cooling Unit, Cooling Wrap, and Thermal Cap. It is intended for use in clinical settings under professional supervision and can be used multiple times with proper cleaning and maintenance.
What is the regulatory status of the DigniCap Delta?
The DigniCap Delta has received FDA 510(k) clearance (K191166) as a substantially equivalent device, classified as Class II under regulation number 878.4360, with product code PMC. This clearance indicates it meets the FDA's requirements for safety and effectiveness.
How does the DigniCap Delta system work?
The system works through a thermoelectric cooling unit with an integrated control system operated via touch screen monitor. This unit circulates temperature-controlled coolant through a hose to a Cooling Wrap containing fluid channels, which reduces scalp temperature during chemotherapy treatments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Home - Dignitana, Delta - DigniCap Scalp Cooling System, PDF User Manual - dignitana.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191166 | Class II | Active |
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Manufacturer
- Manufacturer
- Dignitana, Inc.
Sources (1)
- FDA 510(k) K191166 24 fields · synced Sep 24, 2026