Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016405041

FEI Number

3016405041

Entity Name

Norlase INC

City/State/Country

Redwood City, CA, US

Establishment Address

895 Hurlingame Ave, Redwood City, CA 94063, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Norlase ApS (Owner Number: 10061124)

Owner / Operator Contact Address

Brydehusvej 13, Ballerup, DK-84 2750, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242397

PMA Number

N/A

All Registered Proprietary Names

LEAF ECHO LYNX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2019-08-27
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2022-11-22
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2024-11-10

Official Correspondent

Jan Bitz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Norlase ApS

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015658550	NORLASE APS	Ballerup Hovedstaden, DK

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K834060	F. & F. Koenigkramer	RELIANCE OPHTHALMIC SLIT LAMP R-083	1984-02-04

Similar Registrations

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2247224	Beaver-Visitec International, Inc	Little Silver, NJ, US
3007851054	Avedro, A Glaukos Company	Burlington, MA, US
2031962	STALLION MEDICAL, INC.	SAN DIEGO, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016405041. Last updated year: 2026. Please use registration number 3016405041 when referencing this establishment in official correspondence.