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510(k) K212630

Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo by Ellex Medical Pty, Ltd. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2021
Date Received
August 19, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type

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  • K081565 — INTEGRE PRO, MODEL L2RY (July 2, 2008)
  • K080423 — INTEGRE, MODEL LP581 (March 11, 2008)
  • K052777 — LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE (March 16, 2006)
  • K041598 — LASEREX, MODEL LP4532 (October 6, 2004)
  • K021550 — LUMENIS SELECTA DUET (August 9, 2002)
  • K003955 — LASEREX INTEGRE, MODEL LP2532 (March 15, 2001)

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