Main information

  • Trade name:
  • Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222494
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Advanced Cosmeceuticals - Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system

ARTG entry for

Medical Device Included Class IIb


Advanced Cosmeceuticals

Postal Address

38 Automotive Drive,WANGARA, WA, 6065


ARTG Start Date


Product category

Medical Device Class IIb



Approval area

Medical Devices


- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.




Lutronic Corporation

Lutronic Center 219 Sowon-ro Deogyang-gu

Goyang-si, Gyeonggi-do,

Korea - Republic of


1. Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system

Product Type

Single Device Product

Effective date



47877 Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system

Intended purpose

SPECTRA is the medical device laser system that is indicated for use in surgical applications requiring the

ablation, removal, incision, and destruction of soft tissue in medical specialities. The device is typically

used for the treatment of epidermal and dermal pigmented lesions such as Freckles Ephelides, Lentigines,

Café-au-lait, Seborrheic Keratosis, Nevus of Ota, Ito, ABNOM, Hori's Macules, Becker's Nevus, Melasma,

Facial Telangiectasia, scars and skin rejuvenation.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at

Public Summary

Page 1 of

Produced at 09.11.2017 at 09:22:12 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit for contact information