CAPSULO

GUDID 03700542625958

Capsulo is indicated for photodisruption of ocular tissue using light energy emitted by a Nd. Yag laser, including discission of the posterior capsule of the eye (posterior capsulotomy) and discission of pupillary membranes (pupillary memebranectomy) in aphakic and pseudophakic patients, and irriditomy.

QUANTEL MEDICAL

Ophthalmic solid-state laser system

• Primary Device ID: 03700542625958
• NIH Device Record Key: 1fed8b4c-8c70-480e-bb8b-8e357e58e74d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAPSULO
• Version Model Number: CAPSULO
• Company DUNS: 738574953
• Company Name: QUANTEL MEDICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700542625958 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220430

FDA Product Code

• HQF: Laser, Ophthalmic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-02
• Device Publish Date: 2025-03-25

Devices Manufactured by QUANTEL MEDICAL

• 03700542625958 - CAPSULO: 2025-04-02Capsulo is indicated for photodisruption of ocular tissue using light energy emitted by a Nd. Yag laser, including discission of the posterior capsule of the eye (posterior capsulotomy) and discission of pupillary membranes (pupillary memebranectomy) in aphakic and pseudophakic patients, and irriditomy.
• 03700542625958 - CAPSULO: 2025-04-02 Capsulo is indicated for photodisruption of ocular tissue using light energy emitted by a Nd. Yag laser, including discission of
• 03700542626009 - POCKET III: 2025-04-02 The POCKET III unit is an ultrasonic pachymeter intended to be used for the measurement of corneal thickness by ultrasonic means
• 03700542625569 - VITRA 2: 2022-01-06 The VITRA 2 is a laser system which emits a treatment beam at 532 nm and is intended for use in photocoagulation of ocular tissu
• 03700542625613 - VITRA 810: 2022-01-06 The Vitra 810 is a laser system which emits a treatment beam at 810 nm and is intended for use in photocoagulation of ocular tis
• 03700542625927 - EASYRET: 2021-10-27 The laser (577 nm Fiber Techology Laser SingleSpot, MultiSpot and Subliminal mode and Slit Lamp Zeiss mode) is a photocoagulator
• 03700542625132 - VITRA: 2021-04-21 Ophthalmic Laser Photocoagulator 532nm MonoSpot Laser Retinal Photocoagulation
• 03700542625286 - SUPRA: 2021-04-21 532nm Ophthalmic Laser System used for Retinal Photocoagulation
• 03700542625316 - SUPRA 577Y: 2021-04-21 577nm Ophthalmic Laser System used for Retinal Photocoagulation