Phototome System 2700
by Laser Media
PMA P850019
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP850019 | Date24 Dec 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Phototome(Tm) System 2700
- Generic Name
- Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
- PMA Number
- FDA Product Code
- LOI
- Device Class
- Class III
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S001
Overview
AI-generated summary, 18 Sep 2026
The Phototome System 2700 is a laser device classified as a neodymium:Yag laser for ophthalmic use, specifically for applications other than posterior capsulotomy and cutting pupillary. It is manufactured by Laser Media and identified by the trade name Phototome(TM) System 2700.
The device received FDA PMA approval (P850019) on August 8, 1985, and is classified as a Class III medical device. It is supplied as a system for use in ophthalmic procedures, with no indication of sterility, single-use status, or MRI safety provided in the data.
Other devices from Laser Media
Questions
AI-generated answers, 18 Sep 2026
What type of laser is the Phototome System 2700?
The Phototome System 2700 is a neodymium:Yag laser, as specified in the generic name and openfda fields, which identify it as a Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary.
Is the Phototome System 2700 approved for posterior capsulotomy or cutting pupillary procedures?
No, the device is explicitly defined for ophthalmic uses other than posterior capsulotomy and cutting pupillary, as stated in both the generic_name and openfda device_name fields.
What regulatory pathway was used for the Phototome System 2700?
The Phototome System 2700 received approval through the FDA Premarket Approval (PMA) process, as indicated by the AUTHORIZATIONS field showing FDA_PMA and the PMA number P850019.