PMDA device listing

ビジョンレフラクタ Vision-S 700

PMDA Medical device listing · 13B3X10206VRS700 · Class I

Key facts

PMDA document key 750732_13B3X10206VRS700_A_01
Brand names ビジョンレフラクタ Vision-S 700
General names (JMDN) レフラクタ
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B3X10206VRS700
JMDN codes 35299000
Category code A2200
Marketing authorization holder 製造販売/ルックスオティカジャパン株式会社
Package insert date Dec 1, 2025
PMDA product page pmda.go.jp
Package insert on pmda.go.jp pmda.go.jp

At a glance

  • 1–9 Package insert revisions
  • None Related PMDA documents
  • Listed Listed on the PMDA site
  • Yes Refers to a technical manual

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMDA medical device and IVD listings (Japan)

Medical devices and in vitro diagnostics sold in Japan are approved by the MHLW, certified by a registered certification body or notified, depending on class, and the PMDA publishes each product's package insert. Only identifiers, names and dates are shown here; package insert text and review reports are not reproduced.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, medical device package insert database · Source date:

Browse all PMDA medical device and IVD listings (Japan)