Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008812068

FEI Number

3008812068

Entity Name

CRYOCONCEPTS LP

City/State/Country

Easton, PA, US

Establishment Address

1100 Conroy Place, Easton, PA 18040, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CryoConcepts LP (Owner Number: 10034384)

Owner / Operator Contact Address

1100 Conroy Place, Easton, PA 18040, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242625

PMA Number

N/A

All Registered Proprietary Names

CryoLab Medical CryoLab Aesthetics Skin Clinic NitroClear Histofreezer Histofreezer 17% Salicylic Acid & 27% Lactic Acid Histofreezer Histofreezer Verruca Plana Histofreezer FLEX Skin Clinic Freeze Point for Warts and Skin Tags Dr. Scholl's Freeze Away Skin Tag Remover Dr. Scholl's Skin Tag Complete Care Freezpoint CryoClear CryOmega Skin Clinic Freeze Point for Warts

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-06-21
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2025-09-03
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2020-03-27
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2020-10-05
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2020-10-05
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2020-10-05
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2020-08-07
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2025-09-03
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2022-07-21
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2010-11-29
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2025-09-03

Official Correspondent

Sam Niedbala

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CryoConcepts LP

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K190651	Erbe Elektromedizin GmbH	ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter	2020-01-07
K760953	Spembly Medical , Ltd.	DEEP FREEZE SYSTEM (DFS-30)	1976-11-16

Similar Registrations

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3010140265	CSA Medical	Lexington, MA, US
3012697079	COOL RENEWAL, LLC	Nashville, TN, US
3015612252	INTUITIVE SURGICAL, INC.	Santa Clara, CA, US
3010242262	KONINKLIJKE (ROYAL) UTERMOHLEN N.V.	Wolvega Fryslan, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008812068. Last updated year: 2026. Please use registration number 3008812068 when referencing this establishment in official correspondence.