Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011412640

FEI Number

3011412640

Entity Name

Adler MicroMed, Inc.

City/State/Country

San Diego, CA, US

Establishment Address

6842 Elaine Way, San Diego, CA 92120, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Adler MicroMed, Inc. (Owner Number: 10048608)

Owner / Operator Contact Address

6842 Elaine Way, San Diego, CA 92120, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K070881

PMA Number

N/A

All Registered Proprietary Names

Adler MicroMed Laser Surgery Fiber neoV810 diode laser,neoV980 diode laser, neoV1064 diode laser, neoV1470 diode laser SAPIMED SapiMed SapiMed

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2019-09-20
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2016-05-09
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-03-18
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2016-09-28
KDM	Sigmoidoscope, Rigid, Non-Electrical	Gastroenterology, Urology	Class 2	876.1500	2016-09-28
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2016-09-28

Official Correspondent

Brian Chandler

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Adler MicroMed, 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
K000397	Boston Scientific Corp	SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL	2000-03-07
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-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

Similar Registrations

Registration Number	Establishment Name	Location
3007648354	FETZER MEDICAL GMBH & CO.KG	Tuttlingen Baden-Wurttemberg, DE
3016678045	Schneider ASR B.V.	Rotterdam-Albrandswaard Zuid-Holland, NL
3011137372	Teleflex Medical LLC	Morrisville, NC, US
3004001706	BR SURGICAL LLC	Jacksonville, FL, US
1315756	Weco Manufacturing Group-Henrietta	Rochester, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011412640. Last updated year: 2026. Please use registration number 3011412640 when referencing this establishment in official correspondence.