I-SMART Development LTD. (specification developer, Sutton Coldfield Birmingham, GB): 1 new FDA device listing, incl. light based over the counter wrinkle reduction

I-SMART Development LTD. (Sutton Coldfield Birmingham): 1 new FDA device listing, incl. light based over the counter wrinkle reduction. Its amount of 1 is above the median of 2 (50th percentile). Dated 91 days ago, it serves as a historical benchmark. Score 60/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)

amount: 1 · 50th percentile of 2,709 DeviceEstablishmentPulse records · 0.5x the median

Free preview: all 15 published fields of this record are shown below. Locked: 70 related GB DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentI-SMART Development LTD.
Owner / operatorI-smart marketing/development LTD.
RoleSpecification developer (outsources manufacturing)
Establishment typesDevelop Specifications But Do Not Manufacture At This Facility
LocationSutton Coldfield Birmingham, GB
New listings1
DevicesLight Based Over The Counter Wrinkle Reduction
Product codesOHS
Device classesClass II
Medical specialtiesGeneral, Plastic Surgery
Brand names5 wavelength LED facemask (TN2508); Lumavance LED facemask; faceLITE PRO; LUMA PRO Plus
First new listing2026-08-07
Latest new listing2026-08-07
FDA registration number3013481783
Registration expires2026-12-31
amount percentile50th of 2,709 (median 2, 0.5x median)
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL

  • Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
  • Record date: 2026-08-07
  • Data refreshed: 2026-11-04
  • Refunds on request within 14 days

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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT

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Peer benchmark and outreach value: I-SMART Development LTD. and 71 GB peers

  • GB DeviceEstablishmentPulse records like this one: 71
  • I-SMART Development LTD.'s amount: 50th percentile of 2,709 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every GB peer: $14,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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60 / 100 Score

  • Brings its own devices to market: buys manufacturing, sterilization and QMS help.
  • Class II or III devices: QMS and regulatory demands.

What is the DeviceEstablishmentPulse record for I-SMART Development LTD. in Sutton Coldfield Birmingham?

I-SMART Development LTD. (Sutton Coldfield Birmingham, GB), a specification developer (outsources manufacturing), added 1 FDA device listing on 2026-08-07.

How does I-SMART Development LTD. compare to other DeviceEstablishmentPulse records?

Its amount of 1 sits in the upper half (50th percentile) of 2,709 records; the median is 2. It is 91 days old; check the official source for later updates before acting.

I-SMART Development LTD. vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
I-SMART Development LTD.Sutton Coldfield Birmingham, GB150th2026-08-07
Centinel Spine, LLCWest Chester, PA377th2026-10-22
TORNIER Inc.Columbia City, IN377th2026-10-21
Davol Inc., Sub. C.R. Bard, Inc.Warwick, RI377th2026-10-14

Related records

DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: Foreign establishment

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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.

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