Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031944951

FEI Number

3031944951

Entity Name

ROHRER AESTHETICS, INC.

City/State/Country

Homewood, AL, US

Establishment Address

121 Citation Ct, Homewood, AL 35209, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Rohrer Aesthetics, Inc. (Owner Number: 10091003)

Owner / Operator Contact Address

121 Citation Court, Homewood, AL 35209, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210535

PMA Number

N/A

All Registered Proprietary Names

Gladiator VeinGo Light Bed EpiLaze Pix-E BodySculp Phoenix Pixel8-RF Apollo Spectrum PicoLazer UltraLight LED

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMG	Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5860	2024-07-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-07-05
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-07-05
OUH	Skin Resurfacing Rf Applicator	General, Plastic Surgery	Class 2	878.4400	2024-07-05
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-07-05
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2024-07-05
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-07-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-07-05
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-07-05
OUH	Skin Resurfacing Rf Applicator	General, Plastic Surgery	Class 2	878.4400	2024-07-05
PKT	Laser For Disruption Of Adipocyte Cells For Aesthetic Use	General, Plastic Surgery	Class 2	878.5400	2024-07-05
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2026-05-01
OUH	Skin Resurfacing Rf Applicator	General, Plastic Surgery	Class 2	878.4400	2025-12-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-12-18
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-07-05
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-07-05
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-07-05
OLI	Fat Reducing Low Level Laser	General, Plastic Surgery	Class 2	878.5400	2024-07-05
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-07-05

Official Correspondent

Sandra Hansen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Rohrer Aesthetics, 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
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
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 3031944951. Last updated year: 2026. Please use registration number 3031944951 when referencing this establishment in official correspondence.