Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1035236

FEI Number

1035236

Entity Name

ACUDERM, INC.

City/State/Country

FORT LAUDERDALE, FL, US

Establishment Address

6555 Powerline Road, Suite 114, FORT LAUDERDALE, FL 33309, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ACUDERM, INC. (Owner Number: 1035236)

Owner / Operator Contact Address

6555 Powerline Road, Suite 114, Fort Lauderdale, FL 33309, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K930043

PMA Number

N/A

All Registered Proprietary Names

ACU-PUNCH KIT Acu-Punch ACU-MICRO-NEEDLE ACU-NEEDLE Scissors ACU-GUARD Non-Latex / Sterile Sleeve ACU-EVAC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	1996-09-03
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	1996-09-03
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-12-12
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	1996-09-03
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-12-12
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2007-12-12

Official Correspondent

CHARLES YEH

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ACUDERM, INC.

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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1035236. Last updated year: 2026. Please use registration number 1035236 when referencing this establishment in official correspondence.