Public Access Database for Medical Device Registration

Registration does not represent any form of accreditation, certification or approval by the UK Competent Authority(MHRA)
Where a conformity assessment certificate is listed as expired, existing products already placed on the market prior to the expiry may not be affected by this expiry and can continue to be used. This expiry stops new products being placed on the market until there is a new certificate of conformity

Manufacturer's By Name

By Device

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Manufacturer's Devices - Lumenis Inc

Address:

1870 S Milestone Dr Salt Lake City UT

Salt Lake City

Utah 84104

United States

Authorised Representative/ UK Responsible Person
Name: OMC MEDICAL Ltd
Address:

Planet House North Heath Lane

Horsham

West Sussex RH12 5QE

United Kingdom

Code/Term Type

Slit lamp/laser system control interface Slit lamp/laser system control interface Class IIb

General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system Class IIb

Laser adaptor Laser adaptor Class I

Ophthalmic examination slit lamp Ophthalmic examination slit lamp Class I

Ophthalmic solid-state laser system photodisruption Ophthalmic solid-state laser system photodisruption Class I

Operator eye protection laser filter Operator eye protection laser filter Class I

Indirect binocular laser ophthalmoscope Indirect binocular laser ophthalmoscope Class I

Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Class I

Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Class IIb

Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Class I

Contact details

Freedom of information

0203 080 7272 (manned 10:00-16:00 hours working days) device.registrations@mhra.gov.uk

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Code/Term		Type
Slit lamp/laser system control interface	Slit lamp/laser system control interface	Class IIb
General/multiple surgical frequency-doubled solid-state laser system	General/multiple surgical frequency-doubled solid-state laser system	Class IIb
Laser adaptor	Laser adaptor	Class I
Ophthalmic examination slit lamp	Ophthalmic examination slit lamp	Class I
Ophthalmic solid-state laser system photodisruption	Ophthalmic solid-state laser system photodisruption	Class I
Operator eye protection laser filter	Operator eye protection laser filter	Class I
Indirect binocular laser ophthalmoscope	Indirect binocular laser ophthalmoscope	Class I
Intense pulsed light dry eye therapy unit	Intense pulsed light dry eye therapy unit	Class I
Intense pulsed light dry eye therapy unit	Intense pulsed light dry eye therapy unit	Class IIb
Intense pulsed light dry eye therapy unit	Intense pulsed light dry eye therapy unit	Class I