Unified Business No.

22378963

Industry

Computers, Electronics & Optical Products (2,116)

Main products

Radiation & electro-medical equipment (120)

Location

No. 1-1, Ln. 1, Sec. 3, Bao’an St., Shulin Dist., New Taipei City 238026, Taiwan (R.O.C.)↗
New Taipei City (16,829) · Shulin Dist. (2,929)

Listing

Not publicly issued (84,625)

Organisation type

Company Limited by Shares

Representative

Lee Kuei-juei

Phone

02-26881726-239

Exporter

Yes — registered with the Trade Administration

Annual revenue band

< NT$20M estimated

Ownership

Group subsidiary / corporate-held · Sheng Kuang Tou Tzu Co., Ltd.

North American market

FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since at least 2013 (13+ years)

Compliance record

FDA import refusal: 1 product(s), latest 2023-07-20

Certifications 13

• Medical device license (Class II) (794)Official registry Valid until 2031-01-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-01-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-10-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-03-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-11-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-03-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2015-11-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2016-10-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-05-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2017-11-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2015-11-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2016-10-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-10-30 · Taiwan Food and Drug Administration (TFDA)

Patents 2

• 2022 High-power multi-wavelength visible light Raman laser
• 2020 High-power multi-wavelength visible light Raman laser

North American market evidence 11

• FDA 510(k) clearance K152688 2016-06-15
  LightLas Multi-Wavelength Medical Laser System
• FDA 510(k) clearance K142172 2015-02-27
  LIGHTMED TRUSCAN 577
• FDA 510(k) clearance K124043 2013-09-26
  LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM
• FDA 510(k) clearance K103547 2011-11-03
  LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM
• FDA 510(k) clearance K091981 2009-09-28
  LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER
• FDA 510(k) clearance K091534 2009-09-18
  LIGHTLAS MODEL 532
• FDA 510(k) clearance K090774 2009-08-13
  LIGHTLAS SELECTOR
• FDA 510(k) clearance K021538 2002-08-08
  LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR
• FDA 510(k) clearance K010372 2001-08-22
  LIGHTLAS 532 PHOTOCOAGULATOR
• FDA medical device registration 3008156177 2007-12-31 – 2019-05-26
  Laser, Ophthalmic; Powered Laser Surgical Instrument; Table, Instrument, Powered, Ophthalmic
• FDA import refusal 3003559308 2023-07-20
  LASER, OPHTHALMIC

Similar companies 10

• SMEDTRUM MEDICAL TECHNOLOGY CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class II), Radiation & electromedical equipment manufacturing
• INSIGHT MEDICAL SOLUTIONS INC. · Hsinchu City < NT$20M estimated
  Shared: Medical device license (Class II), Radiation & electromedical equipment manufacturing
• PO YE X-RAY MFG. CORP. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class II), Radiation & electromedical equipment manufacturing
• Pai Chen Technology Co., Ltd. · Changhua County NT$20–100M estimated
  Shared: Medical device license (Class II)
• AAXTER CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class II)
• Wei Feng Technology Co., Ltd. · Taoyuan City NT$100–500M estimated
  Shared: Medical device license (Class II)
• GOOD YEAR ELECTRONIC CO., LTD. · Taoyuan City NT$20–100M estimated
  Shared: Radiation & electromedical equipment manufacturing
• ROOTI LABS LIMITED · Taipei City < NT$20M estimated
  Shared: Medical device license (Class II)
• VMED TECHNOLOGY CORP. · New Taipei City NT$20–100M estimated
  Shared: Medical device license (Class II)
• ACOMED INDUSTRIAL CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class II)

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